BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX LEAD

    MDR report key: 3923499 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14769
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 6, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. THE NOISE COULD NOT BE REPLICATED WITH POCKET MANIPULATION AND PROVOCATIVE TESTING. THE PATIENTS MEDICAL CONDITION WAS GOOD. THE PATIENT WOULD BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION ON (B)(6) 2015 NOTES THE LEAD CONTINUED TO EXHIBIT OVERSENSING DURING FOLLOW-UP. THE PHYSICIAN HAD PREFERRED TO DO NOTHING. THE PATIENTS MEDICAL CONDITION WAS GOOD. THE LEAD REMAINED IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION INDICATES THE LEAD CONTINUES TO EXHIBIT OVERSENSING. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399556 ISOFLEX LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1944/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1