FDA Adverse Event
Injury
Summary report: N
AVISTA MRI
MDR report key: 18289914
·
Received December 8, 2023
Report
- Report Number
- 3006630150-2023-07717
- Event Type
- Injury
- Date Received
- December 8, 2023
- Date of Event
- November 14, 2023
- Report Date
- December 8, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729904816
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7080814.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LEADS MIGRATED AND THE PATIENT EXPERIENCED LACK OF COVERAGE ON PAIN AREAS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY WITH GREAT COVERAGE. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1365314 | AVISTA MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-56 | 7080090 | 08714729904816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Required Intervention |