BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 3890794 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04350
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    June 27, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY THE 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

    NEW INFORMATION RECEIVED NOTES THAT FURTHER EPISODES OF POST-PACED T-WAVE OVERSENSING WERE OBSERVED. PATIENT RECEIVED INAPPROPRIATE ATP THERAPY AND SHOCK. PROGRAMING CHANGES WERE RECOMMENDED, HOWEVER, AFTER REVIEW OF PATIENTS BLOOD WORK, IT WAS DECIDED NOT TO MAKE ANY CHANGES. THE PATIENT IS FINE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS POST-SENSED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE PATIENT DID NOT RECEIVE THERAPY. IT WAS RECOMMENDED THAT THE PHYSICIAN REPROGRAM THE DEVICE. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30283 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD 2207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention