BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 3153093 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01390
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTE
    PMA / PMN Number
    K971474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTPUT PORT OF THE EXTERNAL PULSE GENERATOR (EPG) WAS BROKEN. THE ENGINEER REPLACED THE OUTPUT PORT. THE STATUS OF THE EPG IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256169 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE RICE CREEK MFG 5318D4

    Patients

    Seq Age Sex Outcome Treatment
    1