BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17530255 · Received August 12, 2023

    Report

    Report Number
    MW5137175
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    September 8, 2020
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SVC LEAD IMPEDANCE WARNING ON (B)(6) 2020. RV DEFIB LEAD IMPEDANCE W RNING ON (B)(6) 2020. LEFT VENTRICULAR LVTIP TO RVCOIL LEAD IMPEDANCE WARNING ON (B)(6) 2020. RVTIP TO RVCOIL LEAD IMPEDANCE WARNING ON (B)(6) 2020. THE PATIENT ALERT SOUNDED FOR HIGH IMPEDANCES ON (B)(6) 2020. THERE WAS A SUDDEN JUMP IN RV COIL LEAD IMPEDANCE. THE PDD FILE SHOWS THAT ALL VECTORS THAT INCLUDE THE RV COIL HAVE A SUDDEN INCREASE IN IMPEDANCE; RV DEFIB COIL, RVTIP TO RVCOIL, RVRING TO RVCOIL, LVTIP TO RVCOIL, LVRING TO RVCOIL AND ALSO THE SVC IMPEDANCE WHICH IS MEASURED VIA THE SAME PATHWAY AS THE RV DEFIB COIL IMPEDANCE. (B)(6) 2020 09:00:03 LVTIPRVCOIL: 4047 OHMS (B)(6) 2020 09:00:03 LVRINGRVCOIL: 4047 OHMS (B)(6) 2020 09:00:06 DEFIB (RV COIL) 254 OHMS (B)(6) 2020 09:00:07 SVC COIL: 254 OHMS (B)(6) 2020 09:00:01 RVTIPRVCOIL: 4047 OHMS (B)(6) 2020 09:00:01 RVRINGRVCOIL: 1406 OHMS THI SUDDEN INCREASE IN RV COIL IMPEDANCE IS AN INDICATION FOR A FRACTURE OF THE RV COIL. (B)(4). 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
    728765 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS SD65/16

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown