BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 3880018 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03403
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 20, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST SENSED T WAVE OVERSENSING WAS NOTED. THE PT RECEIVED INAPPROPRIATE HV THERAPY. REPROGRAMMING AND CHANGING THE VENTRICULAR POST SENSED THRESHOLD WERE RECOMMENDED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT, WHILE HOSPITALIZED FOR REASONS UNRELATED TO HIS DEVICE, THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE HV THERAPIES DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE HV THERAPY WAS DEACTIVATED WHILE THE PATIENT IS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26023 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD CD2211-36Q

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention