BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR

    MDR report key: 2902590 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00425
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    October 17, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED HIGH IMPEDANCE WAS VERIFIED IN THE LABORATORY. A REVIEW OF THE HV LEAD IMPEDANCE DATA TREND CONFIRMED THE HIGH MEASUREMENTS IN VIVO. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED TESTING EQUIPMENT (ATE) SYSTEM. NO ANOMALIES WERE DETECTED. THE DEVICE MET ALL SPECIFICATIONS. X-RAY INSPECTION REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION HIGH LEAD IMPEDANCE WAS OBSERVED. SUSPECTED LOOSE SETSCREW ISSUE. DURING REVISION IT WAS NOTED THAT THE RV AND SVC COIL PINS WERE NOT SECURE IN THE DEVICE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED. TWO SUCCESSFUL SHOCKS WERE DELIVERED AFTER THE ICD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9485 CURRENT PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR