FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 11984739
·
Received June 11, 2021
Report
- Report Number
- 3006630150-2021-02859
- Event Type
- Injury
- Date Received
- June 11, 2021
- Date of Event
- May 13, 2020
- Report Date
- June 11, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7053129.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 879568 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 367172 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |