FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 11054887
·
Received December 22, 2020
Report
- Report Number
- 3006630150-2020-06330
- Event Type
- Injury
- Date Received
- December 22, 2020
- Date of Event
- December 3, 2020
- Report Date
- December 22, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767688
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8120-70, SERIAL:(B)(4), BATCH: 232602A.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEAD WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1519884 | PRECISION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | 188445 | 08714729767688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |