Recall Z-0805-2014 ยท LNX
Sorin Group Italia S.r.l.
ORCHESTRA/ORCHESTRA PLUS Programmer
| Date | Jan 22, 2014 (initiated Nov 20, 2013) |
| Status | Terminated |
| Reason | Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker. |
| Root cause | Software design |
| Action | On Nov 20 and Nov 25, 2013, the Dear Doctor Letter was sent by certified mail to 1,310 physicians who are following 13,003 patients implanted with a REPLU or ESPRIT pacemakers in the US. Sorin provided the following recommendations to the physicians: You should consider checking the battery impedance of the last follow-up exam. In case the battery impedance is greater than or equal to 3.5k, a follow-up visit must be scheduled within a maximum of 6 months from the last follow-up visit. When pacemaker operation is checked by the simple application of a magnet, a magnet rate less than 95 min-1 |
| Quantity | 1,718 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.