BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1925738 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14029
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 12, 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
    NC, 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 FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND IN/ON THE HELIX MECHANISM AND ITS SLEEVE HEAD. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION. A STYLET WAS STUCK IN THE LEAD-DISTAL COIL. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE RIGHT VENTRICULAR LEAD WAS TOO SHORT FOR THE PATIENT. THE LEAD WAS REPLACED. IT WAS ALSO REPORTED THAT THE REPLACEMENT LEAD HELIX WOULD NOT RETRACT. THE PHYSICIAN THOUGHT THE HELIX MAY HAVE BEEN EXTENDED OUT OF THE BOX AND THE LEAD WAS NOT EXERCISED PRIOR TO IMPLANT. THE LEAD WAS 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other (B)(4) STENT GRAFT| (B)(4) STENT GRAFT| (B)(4) STENT GRAFT| (B)(4) STENT GRAFT