BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3062191 · Received April 16, 2013

    Report

    Report Number
    9614453-2013-00996
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: UPON ANALYSIS, NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, AFTER THE LEAD WAS CONNECTED TO THE DEVICE, NOISE WAS SEEN DURING THE LEAD IMPEDANCE MEASUREMENT. A LOOSE PIN WAS SUSPECTED, BUT UPON CHECKING IT NO PROBLEM WAS OBSERVED. THE DEVICE WAS NOT USED AND WAS REPLACED. NOISE WAS NOT SEEN ON THE REPLACEMENT DEVICE DURING THE LEAD IMPEDANCE MEASUREMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162486 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D354TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) IMPLANTABLE TACHY LEAD