FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 11474109
·
Received March 12, 2021
Report
- Report Number
- 3006630150-2021-00926
- Event Type
- Injury
- Date Received
- March 12, 2021
- Date of Event
- December 1, 2020
- Report Date
- March 12, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8216-50, SERIAL: (B)(4), BATCH: 7053477.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373178 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 366842 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |