MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-09-14 for ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.
[2977387]
Device 2 of 2. Reference mfr report: 1627487-2012-10505. The pt ((b)(6)) received a surgical scs lead and lead anchor for an scs trial. It was reported, the pt received good paresthesia post-operatively until day three when the pt began to feel stimulation in the arm and chest. The clinician decided this event was a failed trial and elected to explant the scs lead and lead anchor. X-ray imagery confirmed lead migration. Following the explant, the physician reported the lead anchor could be unlocked with very little tension.
Patient Sequence No: 1, Text Type: D, B5
[10185330]
Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Sjm defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2012-10506 |
| MDR Report Key | 2750451 |
| Report Source | 01,07 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-08-23 |
| Date of Event | 2012-08-23 |
| Date Mfgr Received | 2012-08-23 |
| 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 | KARIN BECHLER |
| Manufacturer Street | 6901 PRESTON RD. |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723092511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR |
| Generic Name | SCS LEAD ANCHOR |
| Product Code | GYZ |
| Date Received | 2012-09-14 |
| Returned To Mfg | 2012-09-05 |
| Model Number | 1192 |
| Lot Number | 3571621 |
| Device Expiration Date | 2013-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |