FDA Adverse Event
Injury
Summary report: N
PRECISION NOVI
MDR report key: 10225599
·
Received July 2, 2020
Report
- Report Number
- 3006630150-2020-02738
- Event Type
- Injury
- Date Received
- July 2, 2020
- Date of Event
- June 11, 2020
- Report Date
- July 2, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729897835
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7070939 / 7073528.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. IT WAS NOTED THAT THE PATIENT HAD POOR STIMULATION COVERAGE POSTOPERATIVELY. THE EXPLANTED IPG AND LEADS WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 688295 | PRECISION NOVI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1140 | 202380 | 08714729897835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |