FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 12580155
·
Received October 5, 2021
Report
- Report Number
- 3006630150-2021-05580
- Event Type
- Injury
- Date Received
- October 5, 2021
- Date of Event
- November 1, 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
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED WINTER OF 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7072165.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1473348 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 372282 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |