ICD and CRT-D Advisory from Boston Scientific
Boston Scientific issued a product warning on April 5th secondary to battery problems associated with implantable cardiac defibrillators (ICDs) and cardiac resynchronication therapy defibrillators (CRT-Ds) affecting the VITALITY and CONTAK RENEWAL models.
The problem with the batteries is associated with early battery degradation. This may accelerate the time between elective replacement indicator (ERI) and the end of life (EOL), resulting in a window shorter than three months.
The company is requesting that devices be returned. At this point, no reports of shortened life or serious injuries have been reported.
Specific instructions to monitor patients with the suspect devices were issued (pdf). They also sent physicians lists of patients under their care with the devices under scrutiny.
Related stories:
- St. Jude Doing OK Despite ICD Issues
- Should Device Makers Provide Free Training to Doctors
- Yet More Recalls from Guidant
April 10, 2007 Related topics: Product Recalls, Quality, Safety, Errors, Cardiology