FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 18928953
·
Received March 19, 2024
Report
- Report Number
- 3006630150-2024-01580
- Event Type
- Injury
- Date Received
- March 19, 2024
- Date of Event
- December 9, 2021
- Report Date
- March 19, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6)/ (B)(6). BATCH: 7088817 / 7091393.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS IPG WAS NO LONGER WORKING AS INTENDED SINCE LEAD REVISION PROCEDURE (MFR. REPORT NO.: 3006630150-2021-06639). IT WAS NOTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) DEVICE WAS ALSO CAUSING PAIN WITH MOVEMENT AND DURING SEXUAL INTERCOURSE AS WELL AS BRUISING AROUND CERTAIN ACTIVITIES. IT WAS FURTHER NOTED THAT THERE WAS TENDERNESS AROUND THE IPG AND LEAD SITES. THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2553611 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 508951 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Required Intervention |