BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1991531 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02423
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    November 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    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 FOR (B)(4): HELIX DISENGAGED FROM HELICAL CHANNEL. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL OBSERVATIONS OF BLOOD IN/ON HELIX MECHANISM (SLEEVE HEAD) AND IN/ON HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX WOULD NOT DEPLOY ON THE LEAD EVEN AFTER TWENTY TO TWENTY FIVE TURNS AND THE LEAD HAD HIGH IMPEDANCE LEVELS. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY FIXING THE LEAD. THEREFORE, THE LEAD WAS NOT USED, AND WAS REPLACED WITH A DIFFERENT LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX WOULD NOT DEPLOY ON THE LEAD EVEN AFTER TWENTY TO TWENTY FIVE TURNS AND THE LEAD HAD HIGH IMPEDANCE LEVELS. THEREFORE, THE LEAD WAS NOT USED, AND WAS REPLACED WITH A DIFFERENT LEAD. 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 Other