FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA? 16
MDR report key: 23058835
·
Received September 15, 2025
Report
- Report Number
- 3006630150-2025-07629
- Event Type
- Injury
- Date Received
- September 15, 2025
- Date of Event
- August 21, 2025
- Report Date
- September 15, 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
- FL, 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: M365SC2352500 MODEL: SC-2352-50 SERIAL: (B)(6) BATCH: 7070629 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500 MODEL: SC-2352-50 SERIAL: (B)(6) BATCH: 7070667 UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 BATCH: 25329482 UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED ITEMS WILL NOT BE RETURNED AS PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1398665 | WAVEWRITER ALPHA? 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1216 | 586963 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention |