BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK ENCORE

    MDR report key: 5559259 · Received April 7, 2016

    Report

    Report Number
    3004593495-2016-00133
    Event Type
    Malfunction
    Date Received
    April 7, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    KRG
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; THE PROGRAMMER POWERED UP WITH A SYSTEM ERROR. ANALYSIS ALSO FOUND THE PROGRAMMER HAD A FFT (FAST FOURIER TRANSFORM) FIRMWARE ERROR WHEN RUNNING FFT SOFTWARE WHILE RF (RADIO FREQUENCY) HEAD WAS PLUGGED INTO THE PROGRAMMER DUE TO THE RF HEAD DIGITAL PRINTED CIRCUIT BOARD ASSEMBLY. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOWING SERVICE AND REPAIR OF THE PROGRAMMER, FAILURE ANALYSIS WAS PERFORMED ON THE RF HEAD DIGITAL PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). VISUAL INSPECTION REVEALED NO ANOMALIES. THE PCBA WAS ASSEMBLED INTO A KNOWN GOOD UNIT. THE PROGRAMMER WAS THEN POWERED UP. THERE WAS AN ERROR UPON BOOT. AN AUDIBLE HIGH-PITCHED NOISE WAS NOTED COMING FROM THE RF HEAD. THERMAL IMAGING INDICATED TWO ABNORMALLY HEATED COMPONENTS. VERIFIED NO 12-VOLT OUTPUT, THE RF HEAD DIGITAL PCBA WAS DEFECTIVE. WHEN THE PCBA WAS REPLACED, PROPER OPERATION RESULTED. THE SUSPECT PCBA WAS REINSTALLED AND ABNORMAL OPERATION RETURNED. CONCLUSION: THE EVENT SEEN DURING SERVICE AND REPAIR WAS CONFIRMED, THE RF HEAD DIGITAL PCBA WAS DEFECTIVE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY :ANALYSIS CONFIRMED THE REPORTED EVENT; THE PROGRAMMER POWERED UP WITH A SYSTEM ERROR. ANALYSIS ALSO FOUND THE PROGRAMMER HAD A FFT (FINAL FUNCTIONAL TESTING) FIRMWARE ERROR WHEN RUNNING FFT SOFTWARE WHILE RF (RADIO FREQUENCY) HEAD WAS PLUGGED INTO THE PROGRAMMER DUE TO THE RF HEAD DIGITAL PRINTED CIRCUIT BOARD ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR UPON BOOT-UP, WHICH WAS NOT ABLE TO BE CLEARED BY RE-BOOTING. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212351 CARELINK ENCORE PROGRAMMER, PACEMAKER KRG PLEXUS MANUFACTURING SDN. BHD 29901

    Patients

    Seq Age Sex Outcome Treatment
    1