FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 21032193
·
Received December 29, 2024
Report
- Report Number
- 3006630150-2024-09119
- Event Type
- Injury
- Date Received
- December 29, 2024
- Date of Event
- November 14, 2024
- Report Date
- December 29, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8120700, MODEL: SC-8120-70, SERIAL: (B)(6), BATCH: 175764A.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE REMOVED AND DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1813686 | PRECISION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | 173383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention |