N
Patient 1
THE EVENT DATE IS UNKNOWN. THE PATIENT'S WEIGHT WAS UNABLE TO BE OBTAINED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
MAUDE MDR 9908177
- MDR report key
- 9908177
- Report number
- 3006705815-2020-01502
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ANDREA DEITZ
- Address
- 6901 PRESTON ROAD PLANO TX 75024 US
- Phone
- 972-972-9723
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR | SCS IPG | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | LGW | 3662 | 3662 | A000072264 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THEIR IPG SITE. IN TURN, THE PHYSICIAN DECIDED EXPLANT THE PATIENT'S SCS SYSTEM.