BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 1791908 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06994
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DECREASED IMPEDANCE FROM 500 RANGE TO 230 OHMS, AND THE PATIENT WAS FEELING POCKET STIMULATION AT HIGHER OUTPUTS. HIGH THRESHOLDS ALSO REPORTED. THE TECHNICAL CONSULTANT STATED THAT THIS WAS CONSISTENT WITH AN INSULATION ISSUE. FURTHER REPORT OF HIGH THRESHOLDS OF 4 V AND A LEAD WARNING FOR DECREASED IMPEDANCE IN THE LOW 200 OHM RANGE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET TIP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4011 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other ADSR06 IMPLANTABLE PULSE GENERATOR