FDA Adverse Event
Injury
Summary report: N
INGEVITY MRI
MDR report key: 16306868
·
Received February 6, 2023
Report
- Report Number
- 2124215-2023-04908
- Event Type
- Injury
- Date Received
- February 6, 2023
- Date of Event
- February 3, 2023
- Report Date
- March 13, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526523489
- PMA / PMN Number
- P150012/S000
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING HIGH PACING THRESHOLDS AND HIGH IMPEDANCE MEASUREMENTS. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING HIGH PACING THRESHOLDS AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1225665 | INGEVITY MRI | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7742 | 810127 | 00802526523489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Required Intervention| H |