Recall Z-2784-2015 ยท NVZ Pulse Generator, Permanent, Implantable
St Jude Medical Cardiac Rhythm Management Division
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
| Date | Sep 28, 2015 (initiated Aug 18, 2015) |
| Status | Terminated |
| Reason | Some devices exhibit backup VVI operation due to a backup reset. |
| Root cause | Software change control |
| Action | The notification material is in the form of a Physician Letter was delivered to physicians by FedEx overnight service. The mailing went out on August 17, 2015 for receipt on August 18, 2015. The firm's notification letter identifies clinical implications. Clinical Implications In the event that an Ellipse, Fortify Assura, Unify Assura, or Quadra Assura ICD enters the back-up safety mode, the nominal operational settings will be VVI pacing mode, 67 ppm, 5.0v/0.6ms with bipolar pacing output and defibrillation settings of aVF detection rate of 146 bpm and 36J high voltage therapy. In the event |
| Quantity | 259,214 transmitters (U.S. distribution) 23,604 (foreign distribution) |
| Distribution | Worldwide Distribution-US (nationwide) and foreign distribution to the following: Japan, France, Austria, Canada, Italy, Spain, Netherlands, South Africa, Great Britain, Australia, Sweden, Belgium, Finland, Germany, Portugal, Singapore, Norway, Poland, Ireland, Czech Republic. Denmark, Hong Kong, Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.