BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1874639 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11497
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT PACING. THERE WAS OVERSENSING ON THE VENTRICULAR LEAD AND AT ONE POINT DURING THE IMPLANT IT DISLODGED. THE VENTRICULAR LEAD WAS REPOSITIONED AND IMPLANTED SUCCESSFULLY. IT WAS ALSO REPORTED THAT THERE WERE HIGH THRESHOLDS AND HIGH IMPEDANCE ON THE ATRIAL LEAD. THE LEADS REMAIN IN USE. AFTER CLOSURE THEY HAD TO REOPEN THE PATIENT DUE TO ASYSTOLE BEING NOTED. THE DEVICE WAS DIFFICULT TO REPROGRAM AND THEY DECIDED TO EXPLANT AND REPLACE THE DEVICE DUE TO TECHNICAL SERVICES RECOMMENDATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention