BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951456 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00038
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 8, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LWP
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENTS THAT THE GENERATOR TURNED OFF BY ITSELF. ANALYSIS DID FIND THAT THE OUTPUT CONNECTOR WAS OUT OF SPECIFICATION AND THE ATRIAL WIRE WAS PINCHED. (B)(4).

    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 EXTERNAL PULSE GENERATOR TURNED OFF BY ITSELF. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER NOTED THROUGH FOLLOW-UP THAT THERE WAS NOT A PATIENT CONNECTED AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56000 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MANUFACTURING 5348D4

    Patients

    Seq Age Sex Outcome Treatment
    1