FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 18984434
·
Received March 26, 2024
Report
- Report Number
- 3006630150-2024-01821
- Event Type
- Injury
- Date Received
- March 26, 2024
- Date of Event
- March 7, 2024
- Report Date
- March 26, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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-MRI UPN: M365SC2408560 MODEL: SC-2408-56 SERIAL: (B)(6). BATCH: 5022263/5022336.
Description of Event or Problem · 0
IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO INADEQUATE STIMULATION AND THE EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1985050 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 353115 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |