BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIDA VR

    MDR report key: 4161024 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02337
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE RETURNED DEVICE WAS UNABLE TO CONFIRM AN ISSUE.

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. THE RIGHT VENTRICULAR LEAD HAD OVERSENSING, NOISE, AND VERY LOW IMPEDANCE ON THE PACE/SENSE COIL. THE LEAD WAS REPLACED BUT THE IMPEDANCE REMAINED VERY LOW. BECAUSE THERE WAS NO CHANGE IN IMPEDANCE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALSO EXPLANTED AND REPLACED. IT IS UNCLEAR IF IT WAS A LEAD ISSUE, DEVICE ISSUE OR BOTH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642408 EGIDA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D394VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R 693565 LEAD