FDA Adverse Event
Injury
Summary report: N
AVISTA MRI
MDR report key: 9159333
·
Received October 4, 2019
Report
- Report Number
- 3006630150-2019-05549
- Event Type
- Injury
- Date Received
- October 4, 2019
- Date of Event
- March 28, 2019
- Report Date
- October 4, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729904816
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2408-56, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5013475, MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM. MODEL NUMBER/CATALOG NUMBER: SC-1200, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 356272, MODEL/CATALOG DESCRIPTION: PRECISION MONTAGE MRI IPG STERILE KIT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN LEADS AND IPG WERE RELOCATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 950341 | AVISTA MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-56 | 5010410 | 08714729904816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |