BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2201729 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11178
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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): UPON ANALYSIS, NO ANOMALIES FOUND. (B)(4): NO ANOMALIES FOUND, HOWEVER, THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGE AT IMPLANT; FULL LEAD RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, HOWEVER, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGE AT IMPLANT; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE 65 CM LEAD WAS TOO SHORT AS THE PATIENT HAD A PERSISTENT LEFT SUPERIOR VENA CAVA. THE LEAD WAS NOT USED. DURING IMPLANT ATTEMPT OF THE REPLACEMENT, THE LEAD COULD NOT PASS THROUGH THE TRICUSPID VALVE AND THE PHYSICIAN COULD NOT GET A STYLET TO THE LEAD TIP, DESPITE TRYING OVER 15 STYLETS. THE LEAD WAS NOT USED AND WAS REPLACED. DURING IMPLANT ATTEMPT OF THE DEVICE, THE PATIENT COULD NOT BE SHOCKED OUT OF VENTRICULAR FIBRILLATION (VF) AT 35 JOULES. THE DEVICE WAS NOT USED, AND THE COMPETITOR REPLACEMENT WAS ALSO UNABLE TO SHOCK THE PATIENT OUT OF VF. 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 SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other