FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 15940989
·
Received December 8, 2022
Report
- Report Number
- 3006630150-2022-06808
- Event Type
- Injury
- Date Received
- December 8, 2022
- Date of Event
- August 31, 2022
- Report Date
- December 6, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7070608. PRODUCT FAMILY: SCS LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7071706.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT WAS EXPERIENCING A LOSS OF STIMULATION WHEREIN, SHE WAS NO LONGER RECEIVING ANY PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE FULL SCS SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED TO BSC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449951 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 367458 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Required Intervention |