FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 20510395
·
Received October 22, 2024
Report
- Report Number
- 3006630150-2024-07230
- Event Type
- Injury
- Date Received
- October 22, 2024
- Date of Event
- October 1, 2024
- Report Date
- October 22, 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
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT(S) INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7073484. BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7073485.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS). THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS REMOVED. POST OPERATIVELY, THE PATIENT WAS DOING WELL WITH NO REPORTED COMPLICATIONS. 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 |
|---|---|---|---|---|---|---|---|
| 32356 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 374622 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Female | Required Intervention |