FDA Adverse Event
Injury
Summary report: N
AVISTA MRI
MDR report key: 11509261
·
Received March 17, 2021
Report
- Report Number
- 3006630150-2021-01050
- Event Type
- Injury
- Date Received
- March 17, 2021
- Date of Event
- September 17, 2020
- Report Date
- March 17, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729904816
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEAD-MRI; UPN: M365SC2408560; MODEL: SC-2408-56; SERIAL: (B)(4); BATCH: 7070950.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND DISCOMFORT WHEN STIMULATION WAS TURNED ON. X RAY SHOWED THAT THE LEAD HAD MOVED TO A LESS OPTIMAL POSITION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. EXPLANTED LEADS WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406003 | AVISTA MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-56 | 7070899 | 08714729904816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |