BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1991218 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02293
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE 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

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX DISENGAGED FROM THE HELICAL CHANNEL. IT WAS NOTED THAT 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 TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THERE WAS DIFFICULTY POSITIONING/FIXING THE LEAD, SENSING DIFFICULTIES, HIGH IMPEDANCE, AND HIGH/UNSTABLE/VARIABLE THRESHOLD. THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THERE WAS DIFFICULTY POSITIONING/FIXING THE LEAD, SENSING DIFFICULTIES, HIGH IMPEDANCE, AND HIGH/UNSTABLE/VARIABLE THRESHOLD. IT WAS FURTHER REPORTED THAT THE STYLET WAS "NOT MOVEABLE INSIDE THE LEAD". THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS WERE 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 Other