FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA 16
MDR report key: 21365430
·
Received February 12, 2025
Report
- Report Number
- 3006630150-2025-00655
- Event Type
- Injury
- Date Received
- February 12, 2025
- Date of Event
- August 4, 2024
- Report Date
- February 12, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER THE LAST SEVERAL MONTHS FROM THE DATE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7093386/7095835.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND HEADACHE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1042466 | WAVEWRITER ALPHA 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1216 | 586744 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | Required Intervention |