FDA Adverse Event
Injury
Summary report: N
AVISTA MRI
MDR report key: 9820866
·
Received March 11, 2020
Report
- Report Number
- 3006630150-2020-01137
- Event Type
- Injury
- Date Received
- March 11, 2020
- Date of Event
- February 12, 2020
- Report Date
- March 11, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729904816
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2408-56, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5172612, MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT SATISFIED WITH STIMULATION COVERAGE AS IT WAS SUSPECTED THAT THE LEAD HAD MOVED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283553 | AVISTA MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-56 | 5172399 | 08714729904816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |