FDA Adverse Event
Injury
Summary report: N
AVISTA MRI
MDR report key: 17648921
·
Received August 30, 2023
Report
- Report Number
- 3006630150-2023-05169
- Event Type
- Injury
- Date Received
- August 30, 2023
- Date of Event
- August 1, 2016
- Report Date
- August 30, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729904823
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(6) , BATCH: 19099923. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6) , BATCH: 7071235/7071241.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE EXPLANTED. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1288231 | AVISTA MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-74 | 19099923 | 08714729904823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention |