Medtronic Pacemaker Battery Problems May Cause Device to Fail Without Warning: FDA
Battery problems with certain Medtronic pacemakers may cause the devices to suddenly fail, according to a warning issued by federal health officials, who indicate that at least one death has already been linked to the battery problems.
The FDA issued a safety communication on May 7, following three reports of problems where the lithium-ion battery in a pacemaker drained much quicker than expected. Of the three incidents, two involved patients reporting dizziness which ultimately lead to the discovery of the depleted batteries, requiring replacement. The third incident involved a patient death as a result of the Medtronic pacemaker battery failure.
Pacemakers are implantable devices positioned under the skin and are designed to assist the heart’s pumping action to treat fast, irregular, or slow heart rhythms, by applying small electric pulses to either one or both sides of the heart to keep the left and right chambers beating in proper sync. The devices are also used to treat patients susceptible to heart failure by improving the body’s ability to pump blood and distribute oxygen.
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
According to the warning, Medtronic discovered that certain resynchronization therapy pacemakers may be equipped with ceramic capacitors that are susceptible to cracking due to exposure to thermal-mechanical stress during the manufacturing process. The capacitor is a ceramic electrical component that stores the device’s power. The crack may cause an electrical short and deplete the battery in a matter of days.
The affected pacemakers are used in tandem with Medtronic’s MyCreLink monitor, which is designed to receive an Elective Replacement Indicator (ERI) CareAlert notification when the battery life of the devices drop below a certain level. However, Medtronic indicates this alerting feature may fail in the event the capacitor experiences a short, leaving patients and monitoring physicians without any alert or warning that the device will stop working in the near future.
The warning includes certain Medtronic Azure models W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01, Astra models X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01, Percepta models W1TR01, W1TR04, W4TR01, W4TR04, Serena models W1TR02, W1TR05, W4TR02, W4TR05, and Solara models W1TR03, W1TR06, W4TR03, W4TR06.
The warning impacts approximately 266,700 Medtronic pacemakers distributed worldwide, with 131,889 of those sold to healthcare facilities throughout the United States.
Medtronic announced they have a low prediction rate of additional failures and are advising healthcare physicians to continue normal follow-up with their patients to verify the status of the implanted system as well as the clinical effectiveness of the device. Patients with the implanted and affected devices are encourage to seek emergency medical treatment if they begin to experience lightheadedness, dizziness, chest pain, severe shortness of breath or if they lose consciousness.
At this time Medtronic is not recommending physicians replace the batteries of the affected pacemakers, stating patients may experience a higher risk of injury or death from infection during the replacement surgery when compared to the odds of the battery failing.
The FDA urges doctors and patients to report all adverse events linked to the use of these implants to the agency’s MedWatch adverse event reporting program.
JohnDecember 21, 2022 at 12:23 pm
I had a Medtronic Azure Pacemaker Model W3DR01 implanted on the 5th October 2022. I have had over 1000 episodes of chest pains since the implant resulting in several emergency calls requesting an Ambulance. The hospital run their standard blood test to see if there has been any heart damage. They X-Ray my chest, which comes back clear. They re-do my bloods after 6 hours, the troponin levels are fi[Show More]I had a Medtronic Azure Pacemaker Model W3DR01 implanted on the 5th October 2022. I have had over 1000 episodes of chest pains since the implant resulting in several emergency calls requesting an Ambulance. The hospital run their standard blood test to see if there has been any heart damage. They X-Ray my chest, which comes back clear. They re-do my bloods after 6 hours, the troponin levels are fine. They check my Pacemaker settings and make adjustments... if necessary. They tell me the Pacemaker is pulsing fine and they continue to receive the data from the home hub. Yet to-date, I continue to still get chest pains. Before the implant I took 1.25mg of Bisoprolol. In the last 4 weeks they have increased my dosage six fold to 7.5mg of Bisoprolol which is meant to be controlling my severe irregular heartbeat. Every time I have an ECG my irregular heartbeat is still as irregular as ever before. I have more chest pains now than I did before the implant! I decided to check if the Pacemaker I had fitted was known to have any issues... then I came across this site. Is anybody else having similar issues. My Local Hospital Calderdale Royal Infirmary categorically say there is nothing wrong with me. I think I know my own body, and I definitely know when I am getting chest pains. Just wanted to share this with you.
JimSeptember 15, 2020 at 1:41 pm
I had a W1DRO1 implanted in Jan, 2020, only to find this week that I have a battery drain with only 2 1/2 years left. Very disappointed. Medtronics rep says the drain is caused by the upper lead, which they said did not need to be replaced
micheleDecember 20, 2019 at 7:57 pm
I have the pacemaker in the doc put the other one in and my number is the model number is on the top of the list here is the number W1DR01 I don't know if this is my sec one your the first on I had it done this year and other last for 7 months and,I am upset about it
"*" indicates required fields
More Top Stories
A new report highlights how many women and families feel left out of Camp Lejeune settlement negotiations after suffering repeated miscarriages they say were caused by miscarriages on the North Carolina military base.
A Bard Infuse-A-Port lawsuit claims a piece of a failed port catheter broke off, causing a woman to suffer a pulmonary embolism which has resulted in fragments of the device remaining in her heart.
A Wegovy gastroparesis lawsuit blames the weight loss drug for a stomach paralysis problems which left a woman with permanent injuries.