FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 21694060
·
Received March 25, 2025
Report
- Report Number
- 3006630150-2025-01855
- Event Type
- Injury
- Date Received
- March 25, 2025
- Date of Event
- March 5, 2025
- Report Date
- March 25, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT(S) INVOLVED IN THE EVENT: BRAND NAME: INFINION CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7070874. BRAND NAME: INFINION CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7070915.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT FELT AS IF THERE WAS NO DIFFERENCE IN PAIN WITH THE SPINAL CORD STIMULATOR (SCS) ON OR OFF. THE PATIENT WAS OFFERED REPROGRAMMING SESSIONS, HOWEVER, THE PATIENT DECLINED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS EXPLANTED. THE PATIENT WAS DISCHARGED AND RECOVERING AT HOME. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1719699 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 362047 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention |