BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151947 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01214
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 2067L: RADIO FREQUENCY PROGRAMMER HEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE SCREEN "FADED OUT" INTERMITTENTLY; THE DISPLAY WAS FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS FOUND THAT THE PROGRAMMER WAS NOT ABLE TO READ FLOPPY DISKS; FLOPPY DISK DRIVE FOUND OUT OF ELECTRICAL SPECIFICATION. THE SYSTEM FAN WAS FOUND INTERMITTENTLY NOISY. ANALYSIS ALSO FOUND THE PROGRAMMER WILL ONLY ACTIVATE ONE POSITIONING LED (LIGHT EMITTING DIODE) LIGHT ON THE RF (RADIO FREQUENCY) HEAD EVEN WHEN THE HEAD IS DIRECTLY OVER A DEVICE; A PRINTED CIRCUIT BOARD ASSEMBLY WAS FOUND OUT OF ELECTRICAL SPECIFICATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER¿S SCREEN WAS FADED OUT DURING BOOT UP. THE COMPANY REPRESENTATIVE RAN THE SERVICE DISK AND THE PROGRAMMER BOOTED NORMALLY. TECHNICAL SUPPORT (TS) NOTED THAT THE FLOPPY DRIVE WAS BAD SINCE THE PROGRAMMER BOOTED NORMALLY. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253277 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1