FDA Adverse Event
Malfunction
Summary report: N
AVISTA MRI
MDR report key: 13667220
·
Received March 4, 2022
Report
- Report Number
- 3006630150-2022-00847
- Event Type
- Malfunction
- Date Received
- March 4, 2022
- Date of Event
- January 27, 2022
- Report Date
- March 4, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729904816
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2218700, MODEL: SC-2408-56, SERIAL: (B)(4). BATCH: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNDESIRED STIMULATION AND DISCOMFORT DUE TO LEAD HIGH IMPEDANCES. X-RAY REVEALED LEADS DID NOT MOVE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. BSC REPRESENTATIVE LOGGED IT AS A LEAD FRACTURE. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS KEPT BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1596899 | AVISTA MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-56 | 7073956 | 08714729904816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |