BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3153075 · Received June 8, 2013

    Report

    Report Number
    3002807576-2013-00012
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO EMI INTERFERENCE. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256163 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R