MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-11-21 for BRIO 6788 manufactured by St. Jude Medical - Neuromodulation.
[5228126]
It was reported the pt's (b)(6) ipg is not communicating with the clinician or pt programmer and charger. Additionally, it is unk if the ipg and charger. Additionally, it is unk if the ipg could communicate with the programmers or charger prior to implant. In turn, surgical intervention was undertaken to explant and replace the ipg.
Patient Sequence No: 1, Text Type: D, B5
[12583721]
This device is not approved for sale in the us. 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 | 1627487-2014-25680 |
| MDR Report Key | 4283569 |
| Report Source | 01,07 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-10-27 |
| Date of Event | 2014-10-27 |
| Date Mfgr Received | 2014-10-27 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-12-01 |
| 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 | BENJYNA OBASUYI |
| Manufacturer Street | 6901 PRESTON RD. |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9725264659 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRIO |
| Generic Name | DBS IPG |
| Product Code | IPG |
| Date Received | 2014-11-21 |
| Returned To Mfg | 2014-11-04 |
| Model Number | 6788 |
| Lot Number | 3949170 |
| Device Expiration Date | 2015-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2014-11-21 |