BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1072572 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03985
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    September 24, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY BENCH TESTING FOUND AN INTERMITTENT VENTRICULAR OUTPUT WHEN STRESS WAS PUT ON THE LEAD, CAUSING THE IMPEDANCE TO FLUCTUATE. FURTHER ANALYSIS DETERMINED THIS WAS THE RESULT OF A MISSHAPEN VENTRICLE MULTI BEAM CONNECTOR, WHICH WAS NOT MAKING CONTINUOUS CONTACT WITH THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE. THE LEAD WAS REPLACED. SEVERAL MONTHS LATER, THERE WAS HIGH IMPEDANCE ON THE NEW LEAD AS MEASURED THROUGH THE DEVICE, BUT THE LEAD TESTED OK SEPARATELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD| 5592 IMPLANTABLE PACING LEAD