FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 12163400
·
Received July 13, 2021
Report
- Report Number
- 3006630150-2021-03754
- Event Type
- Injury
- Date Received
- July 13, 2021
- Date of Event
- June 21, 2021
- Report Date
- July 13, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789550
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500 , MODEL: SC-2352-50 , SERIAL: (B)(4), BATCH: 7070241.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT EXPERIENCED LOSS OF STIMULATION AFTER A FALL. XRAY EXAMINATION CONFIRMED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE RE-POSITIONED BACK TO WHERE THEY WERE PRIOR TO THE FALL. THE PATIENT WAS PROGRAMMED SUCCESSFULLY POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1058734 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-50 | 3149733 | 08714729789550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |