FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 17597602
·
Received August 22, 2023
Report
- Report Number
- 3006630150-2023-04958
- Event Type
- Injury
- Date Received
- August 22, 2023
- Date of Event
- March 24, 2022
- Report Date
- August 22, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN OVER A YEAR. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI: UPN: M365SC12000, MODEL: SC-1200, SERIAL: (B)(6), BATCH: 358595. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7031334/5096461/5096958. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 5081656/5080709.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF PER HOSPITAL PROTOCOL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306982 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 357700 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention |