BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2053054 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05757
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED AND ANALYZED. THE DISTAL LEAD CONDUCTOR WAS FRACTURED, DISTAL AND PROXIMAL CONDUCTOR FLEXED AND THE FRACTURED DEFIBRILLATION-SUPERIOR VENA CAVA (SVC) COIL WAS PULLED/STRETCHED/OVERSTRESS. THE DEFIBRILLATION - (SVC) CONDUCTOR WAS EXPOSED KINKED/BUCKLED, PULLED/STRETCHED/OVERSTRESS. THERE WAS BLOOD ON THE DISTAL CONDUCTOR NOT OBSTRUCTED. THE OUTER LEAD INSULATION HAD COSMETIC DEPRESSION AND THE OVERLAY TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC) AND WAS KINKED/BUCKLED. THE LEAD WAS STRETCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HIGH VOLTAGE ELECTRODE IMPEDANCE WAS OUT OF RANGE AND THE HV TREND SHOWED IT HAD BEEN OUT OF RANGE FOR A LONG TIME. A DEFIBRILLATION TEST WAS PERFORMED WITH SUCCESS; THEREFORE, THE RV LEAD WAS LEFT IMPLANTED 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 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB