BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 2953320 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00318
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 21, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTD
    PMA / PMN Number
    K844974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD LOW IMPEDANCE IN BIPOLAR AND HIGHER IMPEDANCE IN UNIPOLAR. THE DEVICE WAS THOUGHT TO HAVE BEEN AT END OF LIFE FOR SOME TIME AND IT COULD NOT BE INTERROGATED. THE DEVICE WAS SCHEDULED TO BE REPLACED. THE LEAD STATUS IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57303 TARGET TIP ADAPTOR, LEAD, PACEMAKER DTD RICE CREEK MFG 451253

    Patients

    Seq Age Sex Outcome Treatment
    1 4012 IMPLANTABLE PACING LEAD