FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 19798090
·
Received July 22, 2024
Report
- Report Number
- 3006630150-2024-04681
- Event Type
- Injury
- Date Received
- July 22, 2024
- Date of Event
- January 30, 2024
- Report Date
- July 19, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7081678/7081961.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND WAS ELECTROCUTED WHEN CHARGING. IT WAS ALSO NOTED THAT THE PATIENT WAS NOT GETTING COVERAGE ON ALL PAIN AREAS DESPITE REPROGRAMMING ATTEMPT, AS ONE OF THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT IPG AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248942 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 569213 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention |