BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2964696 · Received February 15, 2013

    Report

    Report Number
    2182208-2013-00422
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    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

    EVALUATION SUMMARY (B)(4): THE RADIO FREQUENCY PROGRAMMER HEAD WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT DEVICES COULD NOT BE INTERROGATED UNLESS A HAND WAS HELD ON THE CORD CONNECTION TO THE PROGRAMMER. HOWEVER, THE PROGRAMMER HEAD DID FAIL ALL UPLINK/AMPLITUDE TESTS ON THE VXI TESTER. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 2090AA4, PROGRAMMER. (B)(4).

    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).

    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 DEVICES COULD NOT BE INTERROGATED UNLESS HOLDING A HAND ON THE CORD CONNECTION TO THE PROGRAMMER. THE PROGRAMMER AND RF (RADIO FREQUENCY) HEAD WERE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICES COULD NOT BE INTERROGATED UNLESS HOLDING A HAND ON THE CORD CONNECTION TO THE PROGRAMMER. THE PROGRAMMER AND RF (RADIO FREQUENCY) HEAD WERE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66419 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER