BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 19842489 · Received July 25, 2024

    Report

    Report Number
    MW5157674
    Event Type
    Injury
    Date Received
    July 25, 2024
    Report Date
    June 26, 2024
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEWLY IMPLANTED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEING USED FOR DEFIBRILLATION THRESHOLD TESTING WITH THIS PATIENT'S PRE-EXISTING RIGHT VENTRICULAR (RV) LEAD. VENTRICULAR FIBRILLATION WAS INDUCED; HOWEVER, NO SHOCK WAS DELIVERED, AND THE ICD EXHIBITED (VIA THE PROGRAMMER) CODE 1004, INDICATIVE OF A SHOCK BEING DELIVERED INTO A SHORTED CIRCUIT. THE PATIENT RETURNED TO A NORMAL RHYTHM AND SURGICAL INTERVENTION WAS PERFORMED AND THE ICD AND RV LEAD WERE EXPLANTED AND REPLACED. THE PHYSICIAN BELIEVED THE RV LEAD MAY HAVE BEEN TOUCHING THE CAN IN THE POCKET, THUS CAUSING THE SHORTED CIRCUIT CONDITION DURING SHOCK DELIVERY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996169 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN BIOTRONIK, INC. S60

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention