FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 21325541
·
Received February 6, 2025
Report
- Report Number
- 3006630150-2025-00483
- Event Type
- Injury
- Date Received
- February 6, 2025
- Date of Event
- September 5, 2024
- Report Date
- February 6, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500: MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7071004.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF FROM THE SPINAL COR STIMULATOR (SCS) DEVICES. IT WAS NOTED THAT PADDLE LEADS HAD MULTIPLE CONTACTS OUT. THE PATIENT UNDERWENT A SPINAL COR STIMULATOR (SCS) DEVICES REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS KEPT AT THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623532 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 366980 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Required Intervention |