BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1990534 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02054
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 10, 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
    OH, 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. 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 LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY FOR (B)(4): HELIX DISENGAGED FROM HELICAL CHANNEL. ADDITIONAL FINDINGS OF DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, INNER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY BREACHED CUT, BLOOD IN/ON HELIX MECHANISM (SLEEVE HEAD) AND BLOOD IN/ON HELIX MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD'S HELIX WAS INITIALLY DEPLOYED BUT THE LEAD REQUIRED REPOSITIONING. IT WAS FURTHER REPORTED THAT AFTER RETRACTION, THE LEAD'S HELIX WOULD NOT EXTEND. THE LEAD WAS REMOVED AND REPLACED. 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, THE LEAD'S HELIX WAS INITIALLY DEPLOYED BUT THE LEAD REQUIRED REPOSITIONING DUE TO LOW R-WAVES. IT WAS FURTHER REPORTED THAT AFTER RETRACTION, THE LEAD'S HELIX WOULD NOT EXTEND. THE LEAD WAS REMOVED AND REPLACED. 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 67 YR Other