FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 12069803
·
Received June 25, 2021
Report
- Report Number
- 3006630150-2021-03230
- Event Type
- Injury
- Date Received
- June 25, 2021
- Date of Event
- March 10, 2021
- Report Date
- June 25, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI UPN: (B)(4). MODEL: SC-8416-50 SERIAL: (B)(4). BATCH: 1113451. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: (B)(4). MODEL: SC-4316 SERIAL: NA. BATCH: 24553984.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED AND DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 963402 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 365435 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |