BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 1954687 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00471
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 5, 2010
    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
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT WAS CONFIRMED IN THE LABORATORY. BENCH AND THE AUTOMATED ELECTRICAL TEST SYSTEM TESTS REVEALED THAT THE DEVICE EXHIBITED HIGH ATRIAL IMPEDANCE MEASUREMENTS. AFTER THE DEVICE WAS CUT OPEN, FURTHER ANALYSIS FOUND A CONNECTION ISSUE WITH THE ARING CONTACT SPRING WITHIN THE CONNECTOR BLOCK. IT IS BELIEVED THAT THE ARING SPRING WAS NOT MAKING FULL CONTACT WITH THE ARING LEAD ELECTRODE, CAUSING HIGH IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY DUE TO NOISE. REVIEW OF THE EGMS SHOWED NON- PHYSIOLOGIC NOISE. DURING THE SURGICAL PROCEDURE, IT WAS FOUND THAT THE SETSCREW WAS TIGHT. HOWEVER, THE ATRIAL LEAD SHOWED HIGH PACING IMPEDANCE ON THE DEVICE, AND ON THE PSA, IT SHOWED NORMAL VALUE. THE PHYSICIAN THOUGHT THE DEVICE WAS HAVING A CONNECTION ISSUE; HENCE, THE DEVICE WAS EXPLANTED. THE ASSOCIATED RV LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention (B)(4)