FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 21289881
·
Received February 3, 2025
Report
- Report Number
- 3006630150-2025-00360
- Event Type
- Injury
- Date Received
- February 3, 2025
- Date of Event
- January 9, 2024
- Report Date
- February 2, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7060892. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180, MODEL: SC-4318, BATCH: 25076110.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2116221 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1200 | 365902 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | Required Intervention |