FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 15515026
·
Received September 30, 2022
Report
- Report Number
- 3006630150-2022-05147
- Event Type
- Injury
- Date Received
- September 30, 2022
- Date of Event
- September 6, 2022
- Report Date
- September 29, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 5162770/5162770.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE EXPLANTED. ALL EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1633749 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 365122 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |