WAVEWRITER ALPHA
Report
- Report Number
- 3006630150-2022-03522
- Event Type
- Injury
- Date Received
- July 18, 2022
- Date of Event
- June 7, 2022
- Report Date
- September 29, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EXACT DATE UNKNOWN, EVENT OCCURRED A FEW WEEKS AFTER THE IMPLANT DATE.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9208150 . MODEL: SC-9208-15. SERIAL: (B)(6). BATCH: 7071553.
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. DRAINAGE FROM THE IPG INCISION SITE WAS NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS HOSPITALIZED AND THE IPG POCKET WAS WASHED OUT.
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. DRAINAGE FROM THE IPG INCISION SITE WAS NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS HOSPITALIZED AND THE IPG POCKET WAS WASHED OUT. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333644 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 537884 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Female | Hospitalization| R |