BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1992326 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02770
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): HELIX DISENGAGED FROM HELICAL CHANNEL. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL FINDINGS OF HELIX DISTORTED/BENT AND BLOOD IN/ON HELIX MECHANISM. THE ANALYST COMMENTED THAT THE STYLET TEST WAS PERFORMED WITH A NEW STYLET. THE STYLET THAT WAS RETURNED WITH THE LEAD WAS BENT. THE STYLET WAS RETURNED AND ANALYZED. THE STYLET WAS BENT AND AN ADDITIONAL FINDING OF DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE FRICTION COMPLAINT IS LIKELY DUE TO THE STYLET BEING BENT, DAMAGED AT IMPLANT.

    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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEAD, THERE WAS A LOT OF FRICTION BETWEEN THE LEAD AND THE INTRODUCER AND BETWEEN THE STYLET AND THE LEAD. THERE WAS ERRATIC LEAD BEHAVIOR DURING THE REMOVAL OF THE STYLET. DURING EXTRACTION OF THE LEAD, THE HELIX STUCK IN THE TISSUE. THE LEAD WAS ATTEMPTED AND NOT USED. A NEW LEAD WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEAD, THERE WAS A LOT OF FRICTION BETWEEN THE LEAD AND THE INTRODUCER AND BETWEEN THE STYLET AND THE LEAD. THERE WAS ERRATIC LEAD BEHAVIOR DURING THE REMOVAL OF THE STYLET. DURING EXTRACTION OF THE LEAD, THE HELIX STUCK IN THE TISSUE. THE LEAD WAS ATTEMPTED AND NOT USED. A NEW LEAD WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS 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 Other