BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17517227 · Received August 11, 2023

    Report

    Report Number
    MW5124176
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    August 10, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDICAL RECORDS WAS NOTIFIED ON 7/25/2012 THAT THIS PRODUCT WAS IMPLANTED ON (B)(6) 2003 AND WAS TAKEN OUT-OF-SERVICE ON (B)(6) 2008 DUE TO AN UNKNOWN REASON. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6). 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
    762423 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC 6726

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown