BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1921746 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12677
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 3, 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. EVALUATION SUMMARY: (B)(4) THE ANALYSIS RESULTS REVEALED THAT THE OUTER INSULATION WAS BREACHED/CUT. THE FULL LEAD WAS RECEIVED FOR ANALYSIS. FURTHER TESTING REVEALED THE OUTER INSULATON WAS MELTED, THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD WAS IN/ON THE HELIX/LOBE MECHANISM, AND THERE WAS APPARANT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD A LOW IMPEDANCE MEASUREMENT AND A HIGH THRESHOLD. DURING THE LEAD REVISION IT WAS NOTED THAT THE LEAD HAD DISLODGED AND APPEARED TO HAVE A NICK IN THE OUTER INSULATION. THE 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R P1501DR IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD