FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 20111386
·
Received August 30, 2024
Report
- Report Number
- 3006630150-2024-05797
- Event Type
- Injury
- Date Received
- August 30, 2024
- Date of Event
- November 21, 2020
- Report Date
- August 30, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN:M365SC8216500. MODEL:SC-8216-50. SERIAL: (B)(6). BATCH: 7070225.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) DEVICE WAS NOT PROVIDING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IMPLANTABLE PULSE GENERATOR (IPG) AND SCS PADDLE LEAD WERE NOT RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1314273 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 367408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |