FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA PRIME
MDR report key: 20341064
·
Received October 1, 2024
Report
- Report Number
- 3006630150-2024-06532
- Event Type
- Injury
- Date Received
- October 1, 2024
- Date of Event
- September 10, 2024
- Report Date
- September 30, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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-LINEAR LEADS UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5133293/5138992.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATION LEAD HAD MIGRATED AND RESULTED TO LOST COVERAGE FOR THE NECK PAIN. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN AS PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2369165 | WAVEWRITER ALPHA PRIME | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1432 | 216571 | 08714729985075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Required Intervention |