N
Patient 1
MODEL NUMBER/CATALOG NUMBER: SC-1110, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 802543, MODEL/CATALOG DESCRIPTION: SCS IPG2 DUAL ARRAY RECHARGABLE IPG. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN.
MAUDE MDR 9908745
- MDR report key
- 9908745
- Report number
- 3006630150-2020-01570
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-03-25
- 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
- TALAR TAHMASIAN
- Address
- 25155 RYE CANYON LOOP VALENCIA CA 91355 US
- Phone
- 661-661-6619
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PRECISION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | BOSTON SCIENTIFIC NEUROMODULATION | LGW | SC-1110 | SC-1110 | 701756 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING FREQUENT IPG CHARGING AND FAST BATTERY DEPLETION. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.