BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRINSIC

    MDR report key: 2090454 · Received May 16, 2011

    Report

    Report Number
    6000144-2011-02075
    Event Type
    Death
    Date Received
    May 16, 2011
    Date of Event
    June 6, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Adverse Event
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. ADDITIONALLY IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISPORTED, OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. ADDITIONALLY IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISPORTED, OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS EXPIRED. THE PATIENT'S SPOUSE CALLED AND ASKED "WHY DIDN'T THE DEVICE SAVE HIM." THE PATIENT "HAD NOT BEEN FEELING WELL THAT DAY" AND HAD A SIGNIFICANT HISTORY OF VENTRICULAR TACHICARDIA, VENTRICULAR FIBRILLAITON, AND MYCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| O