MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-12-17 for PROTEGE IPG, 16-CHANNEL RECHARGEABLE 3789 manufactured by St. Jude Medical - Neuromodulation.
[130610906]
It was reported that the patient did not recharge the scs ipg per the manufacturer's recommendation. Troubleshooting was attempted, but ipg could not connect with the external devices. In turn, the ipg was inoperable. Surgical intervention may be pending to address the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2018-13053 |
| MDR Report Key | 8172330 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-12-17 |
| Date of Report | 2019-01-23 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2014-06-10 |
| Date Added to Maude | 2018-12-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANDREA DEITZ |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098000 |
| Manufacturer G1 | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Street | 6901 PRESTON RD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTEGE IPG, 16-CHANNEL RECHARGEABLE |
| Generic Name | SCS IPG |
| Product Code | LGW |
| Date Received | 2018-12-17 |
| Model Number | 3789 |
| Lot Number | 4648392 |
| Device Expiration Date | 2016-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Address | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Brand Name | PROTEGE IPG, 16-CHANNEL RECHARGEABLE |
| Generic Name | SCS IPG |
| Product Code | LSW |
| Date Received | 2018-12-17 |
| Model Number | 3789 |
| Lot Number | 4648392 |
| Device Expiration Date | 2016-06-28 |
| 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 | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-17 |