FDA Adverse Event
Injury
Summary report: N
PRECISION NOVI
MDR report key: 14189973
·
Received April 22, 2022
Report
- Report Number
- 3006630150-2022-01799
- Event Type
- Injury
- Date Received
- April 22, 2022
- Date of Event
- November 22, 2021
- Report Date
- April 22, 2022
- 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
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: 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: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7071845 / 7071676.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. IT WAS NOTED THAT AN END OF SERVICE MESSAGE WAS RECEIVED ON THE REMOTE CONTROL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 742709 | PRECISION NOVI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1140 | 203282 | 08714729897835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Required Intervention |