BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCUTANEOUS, UNIPOLAR LEAD

    MDR report key: 10188569 · Received June 24, 2020

    Report

    Report Number
    2649622-2020-11932
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    June 10, 2020
    Report Date
    June 24, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169541177
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS HOWEVER PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS VARIABLE. CONCOMITANT MEDICAL PRODUCTS: MODEL: DTBB1D1, CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D); IMPLANTED: (B)(6) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR HIGH VOLTAGE DEFIBRILLATION COIL EPICARDIAL PATCH TRIGGERED AN ALERT FOR RISING AND HIGH IMPEDANCE AND A LEAD FRACTURE IS SUSPECTED. ADDITIONALLY THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL DISPLAYED RISING AND HIGH IMPEDANCE. BOTH LEADS HAVE BEEN CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655083 SUBCUTANEOUS, UNIPOLAR LEAD DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6996SQ58 00643169541177

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R 6721M-50, LEAD / 511211, COMPETITOR LEAD