FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 11969169
·
Received June 9, 2021
Report
- Report Number
- 3006630150-2021-02789
- Event Type
- Injury
- Date Received
- June 9, 2021
- Date of Event
- February 22, 2020
- Report Date
- June 9, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR AGO FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5099660/5100435.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS IPG WAS CAUSING PAIN AND WAS DEFECTIVE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 865978 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 355882 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |