FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 12577664
·
Received October 5, 2021
Report
- Report Number
- 3006630150-2021-05572
- Event Type
- Injury
- Date Received
- October 5, 2021
- Date of Event
- June 2, 2020
- Report Date
- October 5, 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
EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH:7072403/7072433. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 24704688.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. ALL DEVICE COMPONENTS WERE EXPLANTED AND DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1475632 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 368421 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |