BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIDA CRT-D

    MDR report key: 2964377 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00328
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 4, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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: THE DEVICE WAS RETURNED AND ANALYSIS WAS PERFORMED. THERE WERE NO ANOMALIES FOUND. CONCOMITANT PRODUCTS: IMPLANTABLE PACING LEAD: 4194; IMPLANTABLE PACING LEAD: 5076. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD TRIPPED THE LEAD INTEGRITY ALERT WITH OVERSENSING AND NOISE. IT WAS SUSPECTED THAT THE RV LEAD HAD A POSSIBLE FRACTURE. THE RV LEAD WAS CAPPED AND A CHRONIC RV LEAD WAS REACTIVATED. THE RIGHT ATRIAL (RA) LEAD SHOWED A GRADUAL INCREASE TO HIGH IMPEDANCE AND HIGH THRESHOLDS. THE RA LEAD WAS REPLACED. IT WAS ALSO FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHEN ATTEMPTING TO INTERROGATE THE DEVICE HAD A POP UP WINDOW THAT INDICATED "DETECTION NOT ACTIVE" AND THE DEVICE WAS INACTIVE DURING THE ENTIRE FOLLOW-UP APPOINTMENT. THE ICD WAS EXPLANTED 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
    68819 EGIDA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D394TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD