FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA 16
MDR report key: 21014457
·
Received December 24, 2024
Report
- Report Number
- 3006630150-2024-08972
- Event Type
- Injury
- Date Received
- December 24, 2024
- Date of Event
- December 5, 2024
- Report Date
- December 24, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- 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: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7132437. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7132566.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO INADEQUATE STIMULATION. THE PATIENT IS DOING WELL POST OPERATIVELY. EXPLANTED DEVICE WILL NOT RETURN DUE TO FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109698 | WAVEWRITER ALPHA 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1216 | 580798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |