FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 20810879
·
Received November 29, 2024
Report
- Report Number
- 3006630150-2024-08250
- Event Type
- Injury
- Date Received
- November 29, 2024
- Date of Event
- November 8, 2024
- Report Date
- November 29, 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
- FL, 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:M365SC2316500, MODEL:SC-2316-50, SERIAL:(B)(6), BATCH:3206576/7081613. PRODUCT FAMILY: SCS-SPLITTERS, UPN:M365SC3400300, MODEL:SC-3400-30, SERIAL:(B)(6), BATCH: 7070015/7070052.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2612054 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 362134 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Required Intervention |