BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2203436 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11869
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S15
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED DUE TO CLAVICLE RIB CRUSH. IT WAS ALSO NOTED THAT ALL THE CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT AND THE LEAD WAS STRETCHED. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE INNER INSULATION HAD BREACHED METAL ION OXIDIZATION. IT WAS NOTED THAT ALL THE INSULATORS HAD COSMETIC METAL ION OXIDIZATION, THE DISTAL CONDUCTOR WAS STRETCHED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    INFECTION WAS REPORTED. THE LEADS WERE EXPLANTED. 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 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5024M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) TISSUE VALVE| (B)(4) TISSUE VALVE| (B)(4) IMPLANTABLE PULSE GENERATOR