BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 2790513 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15033
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S33
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUOROSCOPY SHOWED SUBCLAVIAN CRUSH AND THE LEAD COMPLETELY FRACTURED IN HALF. THERE WAS ALSO A REPORT OF THE LEAD NOT BEING ABLE TO PACE, HAVING HIGH/UNSTABLE THRESHOLDS, AND HIGH IMPEDANCE. THE LEAD WAS PARTIALLY EXPLANTED, CAPPED, 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 CAPSURE Z IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5534

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 5034 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR