BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1863237 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11404
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    August 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A VENTRICULAR "ELECTRICAL STORM" WITH 2 SHOCKS THAT DID NOT TERMINATE VENTRICULAR TACHYCARDIA. THE VENTRICULAR AND ATRIAL LEADS BOTH HAD HIGH IMPEDENCE. THE VENTRICULAR AND ATRIAL LEADS ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 72 YR Other D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6996 IMPLANTABLE TACHY LEAD