BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2053109 · Received April 13, 2011

    Report

    Report Number
    2182208-2011-00534
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE DEVICE HAD SWITCHED TO THE PACING MODE (VVI 65) USED FOR WHEN THE DEVICE IS AT ERI. THE PATIENT REPORTED FEELING THE DEVICE PACING, DIZZINESS, LIGHTHEADED, LIKE THE DEVICE WASN'T CATCHING THEIR PAUSES AND THAT THEIR HEART RHYTHM WAS GOING FAST AND THEN SLOW. THE IPG WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. DURING THE REPLACEMENT PROCEDURE IT WAS NOTED THAT THE INSULATION ON THE RIGHT ATRIAL (RA) LEAD HAD PULLED BACK FROM THE PROXIMAL END OF THE LEAD AT THE DEVICE HEADER. THE RA LEAD WAS REPAIRED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. LEAD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R UNKNOWN IMPLANTABLE PACING LEAD