WAVEWRITER ALPHA
Report
- Report Number
- 3006630150-2023-08289
- Event Type
- Injury
- Date Received
- January 2, 2024
- Date of Event
- December 1, 2023
- Report Date
- April 15, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: 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)(6). BATCH: 7091001/7092783/7091333/7091247
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CHRONIC INFECTION. SIGNS AND SYMPTOMS OF PAIN, REDNESS AND WOUND DEHISCENCE WERE NOTED. THE PHYSICIAN REPORTED THAT THE INFECTION WAS NOT DUE TO DEVICE AND THAT THE PATIENT WAS DIABETIC AND TAKING IMMUNOSUPPRESSANTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY WITH ANTIBIOTICS.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CHRONIC INFECTION. SIGNS AND SYMPTOMS OF PAIN, REDNESS AND WOUND DEHISCENCE WERE NOTED. THE PHYSICIAN REPORTED THAT THE INFECTION WAS NOT DUE TO DEVICE AND THAT THE PATIENT WAS DIABETIC AND TAKING IMMUNOSUPPRESSANTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY WITH ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1418841 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 570487 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |