PRECISION MONTAGE MRI
Report
- Report Number
- 3006630150-2022-02874
- Event Type
- Injury
- Date Received
- June 15, 2022
- Date of Event
- May 18, 2022
- Report Date
- July 20, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-56, SERIAL: UNK, BATCH: UNK. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: UNK-M-SC-2408-56, MODEL: SC-2408-56, SERIAL: UNK, BATCH: UNK.
THE RETURNED IPG PASSED ALL TESTS PERFORMED AND REVEALED NORMAL DEVICE CHARACTERISTICS.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENTS DEVICE WAS REPROGRAMMED SEVERAL TIMES, HOWEVER, THE REPORTED ISSUE PERSISTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL THE DEVICES WERE REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENTS DEVICE WAS REPROGRAMMED SEVERAL TIMES, HOWEVER, THE REPORTED ISSUE PERSISTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL THE DEVICES WERE REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2807400 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 350514 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |