BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATCH

    MDR report key: 1952780 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23683
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NHW
    PMA / PMN Number
    P910077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEADS REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED AND AN AMENDED REPORT SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THREE MONTHS AGO, THE SHOCK IMPEDANCE VALUES WERE HIGHER THAN 125 OHMS. ON (B)(6) 2010 THE VALUES WERE BETWEEN 60 TO 70 OHMS. THE PATIENT HAS TWO EPICARDIAL DEFIBRILLATION LEADS IMPLANTED (MODELS 0067 AND 0068, SERIAL NUMBERS UNKNOWN) AND A COMPETITOR PACE/SENSE LEAD. A SHOCK TEST WAS NOT PERFORMED DUE TO THE PATIENTS POOR CONDITION. THE LEADS WILL REMAIN IMPLANTED AND MONITORED CLOSELY EVERY THREE MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATCH IMPLANTABLE LEAD NHW GUIDANT PUERTO RICO BV 0068

    Patients

    Seq Age Sex Outcome Treatment
    1 Other