SPECTRA WAVEWRITER
Report
- Report Number
- 3006630150-2022-06578
- Event Type
- Injury
- Date Received
- November 25, 2022
- Date of Event
- November 7, 2022
- Report Date
- December 30, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5159698 / 7043243.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A NEW PAIN AT THE IPG SITE CAUSED BY AN INJECTION ADMINISTERED BY THE PHYSICIAN ON THE SAID SITE. REPROGRAMMING WAS PERFORMED, HOWEVER, UNSUCCESSFUL. THE PATIENT WAS GIVEN INJECTIONS AROUND THE SITE.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A NEW PAIN AT THE IPG SITE CAUSED BY AN INJECTION ADMINISTERED BY THE PHYSICIAN ON THE SAID SITE. REPROGRAMMING WAS PERFORMED, HOWEVER, UNSUCCESSFUL. THE PATIENT WAS GIVEN INJECTIONS AROUND THE SITE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2559730 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 362014 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Required Intervention |