BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C60DR

    MDR report key: 2953709 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00252
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE BATTERY LONGEVITY WAS SHORTER THAN EXPECTED. THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57285 C60DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND C60A3

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R