BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIA VR

    MDR report key: 2954909 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00269
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    December 10, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    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. 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. PRODUCT EVENT SUMMARY: WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE NO ANOMALIES FOUND FOR THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. UPON INTERROGATION, IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED T-WAVE OVERSENSING. IT WAS ALSO DETERMINED THAT THE RWAVES HAD DECREASED SUGGESTING A POTENTIAL DISLODGEMENTOR MIGRATION OF THE LEAD. THE RV LEAD WAS REPOSITIONED, AND DURING THE PROCEDURE, IT WAS FOUND THAT THE PATIENT HAD AN INFECTION. THE RV LEAD AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  WERE REMOVED. SEVERAL WEEKS LATER, A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59101 CARDIA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D384VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| L| R 6944 IMPLANTABLE TACHY LEAD