BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E SERIES S

    MDR report key: 3860307 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01184
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 20, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EIGHT DAYS AFTER IMPLANT, THE PHYSICIAN WAS NOT ABLE TO DETECT THE DEVICE WITH THE PROGRAMMER. THERE WAS NO PACING SIGNAL AND NO BATTERY VOLUME. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342968 E SERIES S PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND E10A1

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R