BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 2183320 · Received July 28, 2011

    Report

    Report Number
    2649622-2011-10908
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    July 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SOME OVERSENSING ON THE RIGHT VENTRICULAR LEAD PRIOR TO HAVING HIP SURGERY. FOLLOWING THE SURGERY THE HOSPITAL STAFF PAGED THE MEDTRONIC EMPLOYEE TO CHECK THE DEVICE AGAIN, THE PATIENT BECAME HYPERTENSIVE AND EXPIRED. THE CAUSE OF DEATH IS LISTED AS A CARDIAC ARREST. NO INDICATIONS HAVE BEEN MADE THAT THE IMPLANTABLE PULSE GENERATOR SYSTEM OR THE OVERSENSING WAS DIRECTLY INVOLVED WITH THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| L| O| R