N
Patient 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.
MAUDE MDR 9908276
- MDR report key
- 9908276
- Report number
- 1627487-2020-03498
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-13
- 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 | EXTENSION, DUAL 4 CHANNEL 30CM | SCS EXTENSION | ST. JUDE MEDICAL - NEUROMODULATION | LGW | 3343 | 3343 | 118105 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. O |
Event Narratives#
D
Patient 1
RELATED MFR REPORTS: 1627487-2020-03494, 1627487-2020-03495 AND 1627487-2020-03496. IT WAS REPORTED THE PATIENT'S SCS LEADS WERE EXHIBITING HIGH IMPEDANCE. REPORTEDLY, THE PATIENT EXPERIENCED A COUPLE OF FALLS IN THE PAST SIX MONTHS. SURGICAL INTERVENTION WAS TAKEN AND THE PATIENT'S ENTIRE SCS SYSTEM WAS REPLACED AND THE REPORTED ISSUE ADDRESSED.