FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 13952014
·
Received March 30, 2022
Report
- Report Number
- 3006630150-2022-01337
- Event Type
- Injury
- Date Received
- March 30, 2022
- Date of Event
- February 18, 2022
- Report Date
- March 30, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7073243.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) SYSTEM WAS NOT PROVIDING PAIN RELIEF. THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED IPG AND LEAD WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2905045 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 519584 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Male | Required Intervention |