MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-09-24 for QUATTRODE 3166 manufactured by St. Jude Medical - Neuromodulation.
[2912528]
The pt rec'd two supraorbital leads (from the same lot) and two occipital leads as part of her neurostimulator system (off-label). It was reported the pt was unhappy with her stimulation coverage and an x-ray showed possible lead migration for her right supraorbital lead. No further info is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[10137398]
Sjm has limited information 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 | 1627487-2012-02377 |
| MDR Report Key | 2762476 |
| Report Source | 07 |
| Date Received | 2012-09-24 |
| Date of Report | 2012-09-05 |
| Date of Event | 2012-09-05 |
| Date Mfgr Received | 2012-09-05 |
| Date Added to Maude | 2012-09-28 |
| 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 | PAIGE MCKELVY |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098528 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUATTRODE |
| Generic Name | SCS LEAD |
| Product Code | LQW |
| Date Received | 2012-09-24 |
| Model Number | 3166 |
| Lot Number | 3714576 |
| Device Expiration Date | 2014-05-01 |
| 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 | 2012-09-24 |