FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 16608181
·
Received March 24, 2023
Report
- Report Number
- 3006630150-2023-01527
- Event Type
- Injury
- Date Received
- March 24, 2023
- Date of Event
- October 11, 2021
- Report Date
- March 24, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(4). BATCH: 5180657/7038273.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD A WORSENING LOW BACK PAIN ESPECIALLY IN THE IPG SITE. IT WAS ALSO NOTED THAT THE DEVICE WAS NOT PROVIDING ADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING SESSIONS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE REMOVED AND WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379355 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 505388 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Required Intervention |