BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1802735 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08710
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. BLOOD WAS IN/ON THE HELIX MECHANISM (SLEEVE HEAD) AND DISTAL CONDUCTOR (NOT OBSTRUCTIVE). THE HELIX WAS DISENGAGED FROM HELICAL CHANNEL.

    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): SHAFT SEAL OUT OF POSITION, AND BLOOD WAS NOTED ON HELIX MECHANISM, HELIX MECHANISM (SLEEVE HEAD), AND DISTAL CONDUCTOR (NOT OBSTRUCTED); FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE RIGHT VENTRICULAR LEAD HAD IMPEDANCES GREATER THAN 2000 OHMS. THE LEAD WAS NOT IMPLANTED. 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 ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention