N
Patient 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
MAUDE MDR 9888459
- MDR report key
- 9888459
- Report number
- 1627487-2020-03340
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-04
- Date received
- 2020-03-27
- 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 | INFINITY? 7 IMPLANTABLE PULSE GENERATOR | DBS IPG | ST. JUDE MEDICAL - NEUROMODULATION | MHY | 6662 | 6662 | 7163746 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-27 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMMATION AT THE IPG SITE AND SIGNS OF INFECTION FOLLOWING THE PERMANENT SCS IMPLANT PROCEDURE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2020 WHEREIN THE IPG SITE WAS DISINFECTED TO PREVENT INFECTION. ADDITIONALLY, THE PATIENT WAS TREATED WITH INJECTION AND MEDICATION.