Medtronic Pacemaker Recall: Kappa 600/700/900 and Sigma 100/200/300
The FDA has notified patients and cardiologists of a Medtronic pacemaker recall for approximately 21,000 Kappa and Sigma pacemakers due to a wiring defect that could cause a severe heart injury or death.
Medtronic first notified physicians and patients of the pacemaker defects in May, reporting that there had been at least two fatalities potentially connected with the wiring. The FDA has now classified the action as a “Class I” recall, which indicates that the product carries a reasonable probability of adverse health consequences or death.
The recall only applies to about 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted throughout the world. Approximately 15,200 patients with Medtronic Kappa pacemakers installed for five years or longer and another 6,100 patients with Medtronic Sigma pacemakers installed for more than five years are included in the recall.
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Learn MoreThe pacemakers contain a defect that can result in separation of the wiring between the circuit board and other components, such as the battery. This can cause a loss of rate response, battery depletion and loss of telemetry or no output. Patients experiencing Medtronic pacemaker problems may show signs of lightheadedness and fainting.
An additional 15,600 Sigma pacemakers may also contain the defect, but these devices were already included in a 2005 advisory involving wire separations caused by a cleaning solvent used during the manufacturing process.
Medtronic Kappa Series 600/700/900 pacemakers and Sigma Series 100/200/300 pacemakers could be affected by this latest recall, with the devices manufactured primarily between November 2000 and November 2002.
According to a letter sent to healthcare professionals on May 18, 2009, Medtronic did not recommend that physicians consider replacing the device unless a patient is pacemaker dependent or a device is already at the elective replacement time.
Medtronic recently resolved a large number of lawsuits filed over a 2005 pacemaker recall and continues to fight claims stemming from an October 2007 Sprint Fidelis defibrillator lead recall. The defibrillator leads were removed from the market after more than 250,000 people had them implanted, when it was discovered that the leads may prematurely fracture or break. This caused many patients to suffer massive electrical shock or fatal injuries when their defibrillator did not work.
Patients with Kappa or Sigma pacemakers should contact their physicians or Medtronic at 1-800-505-4636 to determine if their pacemaker is one of the recalled models. They can also visit the company’s website and enter the serial number for their device.
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3 Comments
JamesJuly 7, 2021 at 2:02 pm
So i started dying in my sleepin 2005 they put a metronic duel chamber pace maker in a month or so later i started having problems they determined a wire came undone and was floating in my body not attached so the dr then went back in and was unable to reinstall wire because of damage so he set it up with one wire ive had problems with it ever since. Unfortunately i lost my wallet with my metrnic [Show More]So i started dying in my sleepin 2005 they put a metronic duel chamber pace maker in a month or so later i started having problems they determined a wire came undone and was floating in my body not attached so the dr then went back in and was unable to reinstall wire because of damage so he set it up with one wire ive had problems with it ever since. Unfortunately i lost my wallet with my metrnic med card and when i turn 18 they took my medicade and disability away so I'm fought for my disability to get it and my Medicaid back so i could have insurance on the device but was denied repeatedly because im able to do a push button job i have two curves in my spine from 3 open heart surgies as an infant i have a curve in the lower part of my spine and the middle part of my spine im going on 30 ive had pacemaker since2005 its 2021 what can i do about this situation any advice and awsers on how to get another metronic card. Ive been force to find jobs to provide for myself pushing my limitations way past what im supposed to because ive heen denied dome many times i was forced to quit appealingly and find work im not supposed to do against dr teling me dont lift over 5 pounds dont raise my left arm above my head but i have to survive somehow since the disability people kept dening me its not my fault i have to do task that could ultimately serverly cause lasting lifetime injuries i blame the system by and the judges for seeing my age and dening me over and over its not my fault i was born with heart problems whitch lead to surgies that gave me two curves in my spine or the heart desiese i have known as bradiocardio and a duel chamber pacemaker wiith only one lead left in it i blame the system for not protecting my rights and for not having a dr since i dont have insurance and cant go see a cardiologist i work a strenuous job and make 9.50 an HR i bring home near 200to 250 and thats not enough for bills food a ND d personal items much less med insurance the way its goin ill uave a heart attack or end up homeless because a system has failed that should protect people like me with life time medical issues since birth but we the people are wrote off as we dont matter the judge makes plenty money why worry about the poor people will just give u a vertic because they dont care about human beings they just wanna hurry thourgh there day to gohave fun must be nice to rush through work lineing there wallets so they can drive fantsy cars take trips around the world and so what about the person life they put in jeopardy because they are having a bad morning or just want to be anywhere else but there i wish they lived my life for a month then they might know what its like to either work or be homeless or to be hungry like hmmm should i eat tonight or should i get some shoes because there worn out and i need them for work .hope yall can help ty for reading this just remember some people have no choice in what they have to do to survive please lmk if theres any hope left in humans because ive lost faith in the system and the people higher-ups the food chain for noone showed me any act of kindness unless they benifit from it i doubt because of the actions they take instead of putting there time to really understand the people and there conditions its just wrote off as just another case
hollyJuly 12, 2016 at 7:05 am
My son has a kappa pace maker model. Ksr901
KristaJuly 23, 2011 at 1:05 am
My father has a Medtronic Kappa 900 DR pacemaker Model #KDR901. Has this been recalled? He is experiencing dizziness and fullness in his head after ambulating 50 ft. Please advise asap.