BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO

    MDR report key: 2090470 · Received May 16, 2011

    Report

    Report Number
    2649622-2011-07568
    Event Type
    Death
    Date Received
    May 16, 2011
    Date of Event
    June 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    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 DISTORTED, 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 DISTORTED, 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 TACHYCARDIA, VENTRICULAR FIBRILLATION, AND MYCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| O