BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2053128 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05785
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 31, 2011
    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 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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    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): NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL FINDINGS OF INNER TUBING KINKED/BUCKLED, BLOOD IN/ON HELIX MECHANISM AND DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT NO THICKNESS WAS FOUND IN THE MIDDLE OF THE LEAD BODY AND THAT THE INTRODUCER TEST WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THERE WAS THICKNESS IN THE MIDDLE OF THE LEAD BODY THAT CREATED NOTICEABLE RESISTANCE DURING THE LEAD INSERTION VIA THE HAEMOSTATIC VALVE. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. 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