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 2018-12-28 for PROCLAIM 7 ELITE 3662 manufactured by St. Jude Medical - Neuromodulation.
[131711907]
It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended. The device has the appropriate level of battery voltage to provide therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2018-13418 |
| MDR Report Key | 8203532 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-12-28 |
| Date of Report | 2019-02-01 |
| Date Mfgr Received | 2019-01-25 |
| Device Manufacturer Date | 2016-06-27 |
| Date Added to Maude | 2018-12-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 1627487/09/12/2017/001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCLAIM 7 ELITE |
| Generic Name | SCS IPG |
| Product Code | LGW |
| Date Received | 2018-12-28 |
| Model Number | 3662 |
| Lot Number | 5543856 |
| Device Expiration Date | 2018-06-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | PROCLAIM 7 ELITE |
| Generic Name | SCS IPG |
| Product Code | LSW |
| Date Received | 2018-12-28 |
| Model Number | 3662 |
| Lot Number | 5543856 |
| Device Expiration Date | 2018-06-27 |
| 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 | 2018-12-28 |