FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 12119280
·
Received July 5, 2021
Report
- Report Number
- 3006630150-2021-03529
- Event Type
- Injury
- Date Received
- July 5, 2021
- Date of Event
- June 11, 2019
- Report Date
- July 5, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED YEARS AGO. EXPLANT DATE: PROCEDURE HAPPENED YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2218-70 SERIAL: (B)(4). BATCH: 1052708/3023816.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE DUE TO SCS WAS NON-FUNCTIONAL. THE EXPLANTED DEVICES WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1012086 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | 18130328 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |