FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 21663579
·
Received March 21, 2025
Report
- Report Number
- 3006630150-2025-01685
- Event Type
- Injury
- Date Received
- March 21, 2025
- Date of Event
- May 24, 2021
- Report Date
- March 21, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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-MRI. UPN: (B)(4). MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: 7072651/7072291.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) FLIPPED AND WAS DIFFICULT IN MAINTAINING A CHARGE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE AND OVERSTIMULATION DESPITE REPROGRAMMING DONE. THE PATIENT WAS ALSO GETTING STIMULATION IN NONTARGET AREA AND HAD PAIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640819 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 508163 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Female | Required Intervention |