BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203785 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12603
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 16, 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
    IN, 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 THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THERE WAS A TIP SEAL OBSERVATION AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH HELIX FULLY EXTENDED. HELIX WILL NOT RETRACT AT THE TIME DUE TO DRIED BLOOD IN THE DISTAL CONDUCTOR PREVENTING TORQUE TRANSFER WHEN THE IS-1 PIN IS ROTATED. IT CANNOT BE DETERMINED AT THE TIME IF THIS CONTRIBUTED TO THE INABILITY OF THE HELIX TO FUNCTION CORRECTLY AT THE IMPLANT/EXPLANT ATTEMPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE LEAD WAS ATTEMPTED TO BE REVISED BUT THE HELIX OF THE LEAD WOULD NOT RETRACT. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. 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 70 YR Hospitalization| R SEDR01 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD