MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-09-14 for ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.
[2974624]
Device 1 of 3. The pt received 2 sch anchors with the same lot number. Reference mfr report: 1627487-2012-03311 and 1627487-2012-03312. It was reported, the pt's scs leads migrated from their original location. The scs lead migration was identified during a reprogramming session. Follow-up identified the pt's scs leads and scs anchors were replaced which resolved the issue.
Patient Sequence No: 1, Text Type: D, B5
[10181750]
Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported. Sjm defers to the pt's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2012-03313 |
| MDR Report Key | 2750296 |
| Report Source | 07 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-08-24 |
| Date Mfgr Received | 2012-08-24 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2012-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RACHEL BLACKWELL |
| Manufacturer Street | 6901 PRESTON RD. |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9725264637 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR |
| Generic Name | SCS ANCHOR |
| Product Code | GYZ |
| Date Received | 2012-09-14 |
| Model Number | 1192 |
| Lot Number | 3562031 |
| Device Expiration Date | 2013-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Address | PLANO TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-14 |