FDA Adverse Event
Injury
Summary report: N
PRECISION NOVI
MDR report key: 12357430
·
Received August 24, 2021
Report
- Report Number
- 3006630150-2021-04710
- Event Type
- Injury
- Date Received
- August 24, 2021
- Date of Event
- March 21, 2019
- Report Date
- August 24, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729897835
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2019. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 20527932/5040377.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS IPG WAS NONFUNCTIONAL. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE WHEREIN A RECHARGEABLE IPG AND AN ADDITIONAL LEAD WAS IMPLANTED. EXPLANTED IPG WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1255008 | PRECISION NOVI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1140 | 21349629 | 08714729897835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |