BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2535K MICRONY K, SR, PKGD/STER

    MDR report key: 7683959 · Received July 12, 2018

    Report

    Report Number
    2017865-2018-10187
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 14, 2018
    Report Date
    July 12, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P970013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, THE PULSE GENERATOR WOULD NOT DISPLAY LEAD IMPEDANCE INFORMATION OR BATTERY LONGEVITY. THE DEVICE WAS RE-INTERROGATED AND STILL SAME ISSUE OCCURRED. LEAD SENSING AND THRESHOLD WERE ABLE TO BE PERFORMED. DEVICE REPLACEMENT WAS DISCUSSED. PATIENT WAS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522972 2535K MICRONY K, SR, PKGD/STER IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2535K

    Patients

    Seq Age Sex Outcome Treatment
    1