BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 2952839 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00147
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 12, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PRODUCT EVENT SUMMARY #THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. GEO EVENT DESCRIPTION: IT WAS REPORTED THAT THE LEAD IMPEDANCE OF THIS LEAD WAS PROGRESSIVLY RISING TO 200 OHM FOR THE HIGH VOLTAGE CONDUCTOR. THE PATIENT COULD NOT BE DEFIBRILLATED. THE ICD WAS REPLACED BECAUSE OF A SETSCREW ISSUE ON THE CONNECTOR SIDE.

    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 THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASING IMPEDANCE AND THEN HIGH IMPEDANCE. ALSO REPORTED WAS THE INABILITY TO DEFIBRILLATE. THE LEAD WAS CAPPED AND REPLACED. FOLLOWING THE PROCEDURE THE DEVICE WAS FOUND TO HAVE A PROBLEM WITH THE HVB PORTION OF THE NEW LEAD CONNECTION INTO THE CONNECTOR AND THE DEVICE WAS EXPLANTED AND REPLACED THE FOLLOWING DAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56432 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 694965 IMPLANTABLE TACHY LEAD