FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 18386077
·
Received December 22, 2023
Report
- Report Number
- 3006630150-2023-08093
- Event Type
- Injury
- Date Received
- December 22, 2023
- Date of Event
- November 30, 2023
- Report Date
- December 22, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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: M365SC8216500. MODEL: SC-8216-50. SERIAL: (B)(6). BATCH: 7072060.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED OF INFECTION DUE TO INCISION HAD OPENED AND THE IPG WAS VISIBLE. THE PATIENT UNDERWENT IPG REPLACEMENT PROCEDURE TO PREVENT INFECTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS NOT RETURN PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1299038 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 581368 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention |