FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA PRIME 16
MDR report key: 20356269
·
Received October 2, 2024
Report
- Report Number
- 3006630150-2024-06581
- Event Type
- Injury
- Date Received
- October 2, 2024
- Date of Event
- August 1, 2024
- Report Date
- October 2, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985068
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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), BATCH: 7131701/7131960.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION DESPITE A MULTIPLE REPROGRAMMING ATTEMPT. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1137526 | WAVEWRITER ALPHA PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1416 | 219957 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Required Intervention |