FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 16329532
·
Received February 8, 2023
Report
- Report Number
- 3006630150-2023-00494
- Event Type
- Injury
- Date Received
- February 8, 2023
- Date of Event
- December 15, 2022
- Report Date
- February 8, 2023
- 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
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5031389/5031381.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT IPG HAD CHARGING ISSUE. IT WAS NOTED ALSO THAT THE SCS SYSTEM WAS NOT WORKING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICE WAS RETAINED AT THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2280887 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 332295 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Required Intervention |