FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 18205633
·
Received November 24, 2023
Report
- Report Number
- 3006630150-2023-07352
- Event Type
- Injury
- Date Received
- November 24, 2023
- Date of Event
- November 1, 2023
- Report Date
- November 24, 2023
- 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
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: 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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6). BATCH: 5030884/5031234.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) DEVICE WAS BROKEN, AND THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1218963 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 364372 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention |