Manufacturing Concerns Raised Over St. Jude Defibrillator Leads

Reports from an inspection of the factory where certain St. Jude defibrillator leads are made suggest that there are serious problems with how the company changes its designs, which increase concerns about the safety of the small wires that are used to connected implanted defibrillators to the heart. 

On Tuesday, the FDA released an inspection report (PDF) that indicates St. Jude has failed to adequately test design changes made to their Durata leads in the wake of a recall issued for older versions that suffered from insulation problems.

The inspection report found that the lead design elements were tested only once, when even the company’s own protocols call for five tests.

Inspectors Concerned About Defibrillator Lead Design Problems

Eleven different issues were cited in the report involving problems with the Durata lead design and manufacturing processes at St. Jude Medical’s Sylmar, California facility. The issues included design verification and validation problems, how the company responded to complaints, and others.

The plant is one of five where St. Jude manfactures cardiac rhythm management products, including lead wires that are used to connect implantable cardioverter defibrillators (ICD) to the heart.

In recent years, St. Jude has faced increased regulatory scrutiny after a number of problems surfaced with different models of their defibrillator leads. 

The wires in some models of St. Jude defibrillator leads have been found to poke through the insulation, resulting in an exposed wire inside the body.  This could cause patients to suffer unnecessary shocks or cause an ICD to fail to deliver a life-saving jolt when needed.

St. Jude Riata Recall Led To Concerns Over Durata Leads

The latest inspection comes as St. Jude tries to shake some concerns that the Durata leads could have similar flaws that lead to the St. Jude Riata recall over lead insulation problems in November of last year.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude defibrillator leads implanted.  Due to risks associated with trying to replace the leads, individuals have not been told to remove the leads unless problems have been confirmed.

The FDA indicated that individuals who received a St. Jude Riata or Riata ST leads should undergo x-ray or other imaging exams to monitor the condition of the leads.  The agency also indicated that doctors should consider remote monitoring for patients with the Riata leads in order to quickly catch electrical problems.

At that time, it was also disclosed that the FDA ordered St. Jude to conduct additional studies on the potential risk of early insulation failures and probelms with the defibrillator leads.  In addition to the Riata leads, the FDA also ordered three-year surveillance studies on newer versions of the St. Jude leads, sold under the names Riata ST Optim and Durata.

A growing number of individuals throughout the United States are now pursuing a product liability lawsuit over the St. Jude Riata leads, alleging that manufacturing defects made the insulation weaker at certain points, allowing the wire to penetrate and become exposed inside the body.