Recall Z-0023-2018 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
St. Jude Medical, Inc.
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
| Date | Sep 12, 2017 |
| Status | Terminated |
| Reason | Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations. |
| Root cause | Software design |
| Action | St. Jude Medical sent an Important Medical Device Advisory letter dated September 12, 2017, to all affected customers. Customers were advised the following: Phase I: ERI Assessment If a patient reports that an ERI message is displayed on the PC, please contact your Abbott Representative to obtain the device-specific generator logs and to conduct the ERI Assessment using the steps in Appendix B prior to making an elective replacement decision. After the ERI Assessment is completed, follow-up communication from your Abbott representative will be provided in order to make appropriate dec |
| Quantity | 3,119 devices |
| Distribution | Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.