BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 17424085 · Received July 31, 2023

    Report

    Report Number
    2124215-2023-40353
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    July 14, 2023
    Report Date
    August 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO LOSS OF CAPTURE. THE PATIENT HAD EXPERIENCED MULTIPLE EPISODES OF SYNCOPE (ONE AT THE MALL AND TWO AT THE HOSPITAL) AND IT WAS NOTED THAT THE RV THRESHOLD HAD INCREASED FROM 0.8 V TO 4 V. X-RAY DID NOT SHOW ANY SIGNS OF LEAD FRACTURE AND THERE DID NOT APPEAR TO BE A CARDIAC PERFORATION. TECHNICAL SERVICES OBSERVED THAT ONE DAY POST-REVISION THE RV THRESHOLD WAS 0.3 V AND THAT FOUR DAYS AFTER THAT, IT INCREASED AGAIN, TO GREATER THAN 3.3 V. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE AND NO ADDITIONAL INTERVENTION HAS BEEN REPORTED. IT WAS ADDITIONALLY REPORTED THAT THE ORIGINAL RV LEAD WAS 7742/1123081. THE LEAD WAS REPLACED ON (B)(6) 2023 WITH LEAD 7842/1182249. THE PATIENT UNDERWENT ANOTHER PROCEDURE ON (B)(6) 2023 TO REPOSITION THE NEW RV LEAD DUE TO THE HIGH THRESHOLD. ONE DAY POST REVISION THE LEAD MEASUREMENTS WERE GOOD AND STABLE. THE MOST CURRENT RV THRESHOLD MEASUREMENT WAS 1.2 V AT 0.4 MS. IT WAS PLANNED TO CONTINUE WEEKLY REMOTE MONITORING FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO LOSS OF CAPTURE. THE PATIENT HAD EXPERIENCED MULTIPLE EPISODES OF SYNCOPE (ONE AT THE MALL AND TWO AT THE HOSPITAL) AND IT WAS NOTED THAT THE RV THRESHOLD HAD INCREASED FROM 0.8 V TO 4 V. X-RAY DID NOT SHOW ANY SIGNS OF LEAD FRACTURE AND THERE DID NOT APPEAR TO BE A CARDIAC PERFORATION. TECHNICAL SERVICES OBSERVED THAT ONE DAY POST-REVISION THE RV THRESHOLD WAS 0.3 V AND THAT FOUR DAYS AFTER THAT, IT INCREASED AGAIN, TO GREATER THAN 3.3 V. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE AND NO ADDITIONAL INTERVENTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908803 INGEVITY MRI IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7742 1123081

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H