FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 11277880
·
Received February 4, 2021
Report
- Report Number
- 3006630150-2021-00268
- Event Type
- Injury
- Date Received
- February 4, 2021
- Date of Event
- January 6, 2021
- Report Date
- February 4, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500 MODEL: SC-8336-50 SERIAL: (B)(4). BATCH: 7071393
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE PAIN, INADEQUATE AND NON-TARGET STIMULATION. THE PATIENT UNDERWENT AN IPG AND A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174753 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 371169 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |