MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-31 for PROCLAIM 7 ELITE 3662ANS manufactured by St. Jude Medical - Neuromodulation.
[146775968]
The results/method and conclusion codes along with investigation results will be provided in the final report. The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.
Patient Sequence No: 1, Text Type: N, H10
[146775969]
It was reported the patient's ipg would not communication following an unrelated surgical procedure on (b)(6) 2019. It was stated the device was not placed into surgery mode. Troubleshooting was unable to resolve the issue. Surgical intervention may be planned as the next course of action.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2019-05878 |
| MDR Report Key | 8660680 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-31 |
| Date of Report | 2019-08-26 |
| Date of Event | 2019-05-13 |
| Date Mfgr Received | 2019-08-25 |
| Device Manufacturer Date | 2018-07-02 |
| Date Added to Maude | 2019-05-31 |
| 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 | 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 | 1627487/06/02/2017/001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCLAIM 7 ELITE |
| Generic Name | SCS IPG |
| Product Code | LGW |
| Date Received | 2019-05-31 |
| Model Number | 3662ANS |
| Lot Number | 6514603 |
| 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 | 2019-05-31 |