BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2202244 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11308
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARELINK TRANSMISSION INDICATED THE RIGHT VENTRICULAR (RV) LEAD HAD A LEAD WARNING AND IMPEDANCES GREATER THAN 9,999 OHMS AND NO CAPTURE. THE PATIENT WAS SEEN AT THE CLINIC AND A LEAD REVISION WAS SCHEDULED. WHEN THE LEAD WAS EVALUATED WITH THE ANALYZER DURING THE RV LEAD REVISION THE R-WAVES WERE INCONSISTENT, IMPEDANCE WAS GREATER THAN 4000 OHMS AND THERE WAS NO CAPTURE AT 5.0 VOLTS. THE RV LEAD 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD