BEUDAMED
    FDA Adverse Event Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1864707 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10972
    Date Received
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CORRECTED ADVERSE EVENT. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. BLOOD WAS OBSERVED IN/ON THE HELIX MECHANISM. (B)(4) ALL INSULATORS BREACHED CUT; THE FULL LEAD WAS RETURNED FOR ANALYSIS. THE PROXIMAL CONDUCTOR WAS FOUND DISTORTED. BLOOD/BODY FLUID WAS OBSERVED ON ALL CONDUCTORS (NOT OBSTRUCTED) AND BLOOD WAS OBSERVED IN/ON THE HELIX MECHANISM. THE LEAD WAS STRETCHED. APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING OPEN HEART SURGERY, THE RIGHT ATRIAL LEAD BECAME DISLODGED. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL LEAD HAD BLOOD IN ITS INSULATION. ADDITIONALLY, THE RIGHT VENTRICULAR LEAD WAS ATTEMPTED TO BE REPOSITIONED, DUE TO VARIABLE R-WAVES; HOWEVER ITS HELIX COULD NOT BE REDEPLOYED. BOTH RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS WERE 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 CAPSUREFIX NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1158T COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1158T COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB