BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951942 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00108
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE HEAD CONNECTOR WAS LOOSE, SO THE PRINTED CIRCUIT BOARD WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY (RF) HEAD CONNECTOR HAD AN INTERMITTENT CONNECTION. REPLACING THE RF HEAD DID NOT RESOLVE THE ISSUE. THE RF HEAD CONNECTOR WAS EITHER BROKEN OR DAMAGED. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY (RF) HEAD CONNECTOR HAD AN INTERMITTENT CONNECTION. REPLACING THE RF HEAD DID NOT RESOLVE THE ISSUE. THE RF HEAD WAS EITHER BROKEN OR DAMAGED. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR REPAIR, WERE ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56403 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1