FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 9699148
·
Received February 12, 2020
Report
- Report Number
- 3006630150-2020-00510
- Event Type
- Injury
- Date Received
- February 12, 2020
- Date of Event
- January 3, 2020
- Report Date
- February 12, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5139121/7043572, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE PATIENT FELT PAIN AT THE LEFT RIB CAUSED BY THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS MOVED TO A MORE SUITABLE POSITION AND THE LEADS WERE UNTANGLED AND LOOPED PROPERLY BEHIND THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166726 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 359754 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |