FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 14843382
·
Received June 28, 2022
Report
- Report Number
- 3006630150-2022-03153
- Event Type
- Injury
- Date Received
- June 28, 2022
- Date of Event
- May 13, 2022
- Report Date
- June 28, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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)(4). BATCH: 7070493.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE OF MULTIPLE REPROGRAMMING DONE AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1813771 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 369985 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |