FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA? 16
MDR report key: 23013227
·
Received September 10, 2025
Report
- Report Number
- 3006630150-2025-07416
- Event Type
- Injury
- Date Received
- September 10, 2025
- Date of Event
- July 11, 2025
- Report Date
- September 10, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7082175, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT HOLDING A CHARGE CAUSING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND SPINAL CORD STIMULATOR (SCS) LEAD WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2519475 | WAVEWRITER ALPHA? 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1216 | 509907 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |