FDA Issues an Alert on Medtronic’s Pacemaker or Cardiac Resynchronization Therapy Pacemaker for its Premature Battery Depletion
FDA Issues an Alert on Medtronic’s Pacemaker or Cardiac Resynchronization Therapy Pacemaker for its Premature Battery Depletion
Shots:
- FDA issues an alert to inform patients and health care practitioners about the unexpected drainage of Medtronic’s implantable pacemakers leading to a serious injury or death. The affected CRT-P includes Azure, Astra, Percepta, Serena and Solara models
- The alert is due to three events where device’s capacitor cracked, without any warning to the patient or health care provider. As of April 10, 2019, 131,889 have been sold in the US and doctors were unable to communicate with the device due to battery depletion resulting in loss of pacemaker function leading to dizziness, death, within a year of pacemaker implantation
- Medtronic’s MyCareLink Monitor helps patients to monitor battery status and general functioning of their implanted pacemaker or CRT-P. the device is designed with ~7.5 and 15 years or 6 and 10 years before requiring battery replacement. The US FDA approves enhancement in the device to detect capacitor failures in new devices, reducing the risk of premature battery depletion
Click here, Click here to read full press release/ article | Ref: FDA | Image: Medtronics