BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAMMER 2090X

    MDR report key: 2865076 · Received December 10, 2012

    Report

    Report Number
    2182208-2012-04071
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 26, 2012
    Report Date
    December 31, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S145
    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. (B)(4).

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE TOUCH PEN WOULD NOT WORK. THE FLEX TAPE WAS REPLACED DURING TROUBLE SHOOTING. IT WAS ALSO NOTED THAT THE PRINTED CIRCUIT BOARD WAS REPLACED DUE TO THE STYLUS CONNECTION NOT FUNCTIONING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PEN (STYLUS) WAS NOT WORKING WITH THE PROGRAMMER. THE DEVICE WAS RETURNED TO SERVICE FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PEN (STYLUS) WAS NOT WORKING WITH THE PROGRAMMER. THE DEVICE WAS RETURNED TO SERVICE FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER 2090X PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ RICE CREEK MFG 2090X

    Patients

    Seq Age Sex Outcome Treatment
    1