FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 18357720
·
Received December 19, 2023
Report
- Report Number
- 3006630150-2023-07950
- Event Type
- Injury
- Date Received
- December 19, 2023
- Date of Event
- August 21, 2023
- Report Date
- December 19, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700, MODEL: SC-8336-70 , SERIAL: (B)(6), BATCH: 7072400.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. IT WAS ALSO NOTED THAT THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT IPG AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1459584 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 546308 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |