FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 20524528
·
Received October 24, 2024
Report
- Report Number
- 3006630150-2024-07276
- Event Type
- Injury
- Date Received
- October 24, 2024
- Date of Event
- August 30, 2023
- Report Date
- October 24, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6) /(B)(6) . BATCH: 5095789/5132926.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) WAS NOT PROVIDING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A SCS EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION SUSPECTED. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2561512 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 374145 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention |