BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD

    MDR report key: 1981985 · Received February 8, 2011

    Report

    Report Number
    6000023-2011-00003
    Event Type
    Injury
    Date Received
    February 8, 2011
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S39
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DISTAL CONDUCTOR FRACTURED, THE PROXIMAL CONDUCTOR WAS FRACTURED, ALL CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS PULLED APART DUE TO OVERSTRESS, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION. IT WAS ALSO NOTED THAT THE LEAD WAS STRETCHED AND THERE WAS A WHITE SUBSTANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD SENSING ISSUES. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE VDD IMPLANTABLE PACING LEAD DTB MEDTRONIC, B.V. 5032S ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR