FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 18918731
·
Received March 15, 2024
Report
- Report Number
- 3006630150-2024-01533
- Event Type
- Injury
- Date Received
- March 15, 2024
- Date of Event
- August 19, 2023
- Report Date
- March 15, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED APPROXIMATELY FIVE TO SIX MONTHS BEFORE EXPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 5101276/5101280.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT WAS NOT RECEIVING ADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND DISPOSED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 536471 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 358600 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Required Intervention |