FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 11293412
·
Received February 8, 2021
Report
- Report Number
- 3006630150-2021-00342
- Event Type
- Injury
- Date Received
- February 8, 2021
- Date of Event
- January 14, 2020
- Report Date
- February 8, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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: 7041157.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND UP INTO THE THORACIC REGION AND HIPS WHETHER THE STIMULATION WAS OFF OR ON. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE STIMULATION. DATABASE ANALYSIS OF THE BATTERY DISCHARGE AND CHARGE PROFILES WERE OBSERVED AND REVEALED NO ANOMALIES. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191826 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 358001 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |