FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 21367209
·
Received February 12, 2025
Report
- Report Number
- 3006630150-2025-00658
- Event Type
- Injury
- Date Received
- February 12, 2025
- Date of Event
- June 17, 2018
- Report Date
- February 12, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7012367.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION ON THE RIB DURING REPROGRAMMING. FOLLOWING THIS, THE PATIENT HAD WEAKNESS IN THE LEFT LEG AND A BURNING SENSATION ON THE RIB. THE PATIENT THEN UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICES WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1163799 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 331231 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |