BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151578 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01144
    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

    EVALUATION SUMMARY: THE PROGRAMMER WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT A RELIABLE ELECTROCARDIOGRAM (EKG) COULD NOT BE OBTAINED UNLESS THE EKG CABLE WAS HELD OR PUSHED UP DUE TO A LOOSE EKG CONNECTOR. ANALYSIS ALSO FOUND THAT THE SYSTEM FAN WAS NOISY. CONCOMITANT PRODUCTS: PRODUCT ID R2067L RADIO FREQUENCY PROGRAMMER HEAD; PRODUCT ID 229047 SOFTWARE ANALYZER. (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. CONCOMITANT PRODUCT: 2290 PACING SYSTEM ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RELIABLE ELECTROCARDIOGRAM (EKG) COULD NOT BE OBTAINED UNLESS THE EKG CABLE WAS HELD OR PUSHED UP. THE PROGRAMMER WAS RETURNED FOR REPAIR OF THE EKG PORT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RELIABLE ELECTROCARDIOGRAM (EKG) COULD NOT BE OBTAINED UNLESS THE EKG CABLE WAS HELD OR PUSHED UP. THE PROGRAMMER WAS RETURNED FOR REPAIR OF THE EKG PORT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252279 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L PROGRAMMER RF (RADIO-FREQUENCY) HEAD