BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152011 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01194
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE A NON-WIRELESS DEVICE, MOVING THE RADIOFREQUENCY (RF) HEAD CONNECTOR CAUSED A LOSS OF TELEMETRY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SALES REPRESENTATIVE (SR) THAT INITIALLY INTERMITTENT TELEMETRY WAS OBSERVED WHEN USING THE RF (RADIO FREQUENCY) HEAD, HOWEVER, NOW THERE IS NO TELEMETRY WHEN USING THE RF HEAD. THE SR REPLACED THE RF HEAD, HOWEVER THIS DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252712 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1