FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 12224845
·
Received July 26, 2021
Report
- Report Number
- 3006630150-2021-04039
- Event Type
- Injury
- Date Received
- July 26, 2021
- Date of Event
- November 8, 2020
- Report Date
- July 26, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: EXACT DATE UNKNOWN, EVENT OCCURRED EIGHT MONTHS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. EXPLANT DATE: EIGHT MONTHS AGO FROM THE AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336700, MODEL: SC-8336-70, SERIAL: (B)(4), BATCH: 7050111.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IPG WAS NOT DOING ANYTHING FOR THE PATIENT. ALL COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1123005 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 353891 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |