BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY ADX XL VDR

    MDR report key: 4861388 · Received June 23, 2015

    Report

    Report Number
    3010215456-2015-00522
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    April 29, 2015
    Report Date
    May 4, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS TO RETRACT FOLLOW-UP REPORT 3010215456-2015-00522, SUBMITTED ON OCTOBER 26, 2015. THIS REPORT WAS ERRONEOUSLY SUBMITTED. ALL SUBMITTED INFORMATION SHOULD BE CORRECTED TO NOT APPLICABLE AND NULL FIELDS. THE NEW INFORMATION REPORTED WAS ALREADY IN FOLLOW-UP REPORT 3010215456-2015-00522, SUBMITTED ON AUGUST 27, 2015.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NEW INFORMATION INDICATED THE ATRIAL LEAD WAS PROGRAMMED OFF.

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED THE LEAD WAS PROGRAMMED OFF. THE PATIENT WOULD BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER DEVICE REPLACEMENT, NO ATRIAL SENSING WAS OBTAINED. X-RAY WAS PERFORMED AND SHOWED THAT LEAD AND DEVICE CONNECTION WAS NOT SUFFICIENT. THE DEVICE REMAINS IMPLANTED AND THE PATIENT IS NOT PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405888 VERITY ADX XL VDR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC. (CRM-KISTA) 5456I S000004264

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention