BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISENSE

    MDR report key: 4231321 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18112
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    August 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 DURING A ROUTINE FOLLOW UP, THE ATRIAL LEAD EXHIBITED NOISE AND LOW IMPEDANCE; INSULATION DAMAGE WAS SUSPECTED. ON (B)(6) DURING ANOTHER FOLLOW UP, THE PHYSICIAN REPROGRAMMED THE DEVICE. THE PATIENT WAS ASYMPTOMATIC AND WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715492 OPTISENSE PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1999/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR