BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1992373 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02801
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THE DEVICE WITH MODEL 6935 IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE LEADS WITH MODEL 6935 AND 6947 ARE PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) HELIX DISENGAGED FROM HELICAL CHANNEL. ADDITIONAL FINDINGS OF THE DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER TUBING KINKED/BUCKLED, BLOOD IN/ON HELIX MECHANISM (SLEEVE HEAD) AND HELIX MECHANISM, TIP SEAL OBSERVATION AND LEAD STRETCHED. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. ADDITIONAL FINDING OF BENT TIP. INVESTIGATOR COMMENTED THAT THE LEAD MET THE SPECIFICATION FOR STRAIGHTNESS IN PASSING THE LEAD INTRODUCER TEST. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT OF THE RIGHT VENTRICULAR LEAD, ITS DISTAL END APPEARED TO BE BENT. IT WAS ALSO REPORTED THAT DURING THE IMPLANT OF ANOTHER LEAD, ITS HELIX WOULD NOT DEPLOY. NEITHER LEAD WAS USED, AND BOTH WERE REPLACED. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other