BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1854675 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09127
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    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. CORRECTION: CONTACT AND FACILITY ADDRESS AND PATIENT OUTCOME. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. FULL LEAD WAS RETURNED AND ANALYZED.

    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 DURING AN IMPLANT ATTEMPT, POSITIONING/FIXATION DIFFICULTY WAS ENCOUNTERED. AS WELL, IT WAS NOTED THE HELIX DEPLOYMENT AND RETRACTION WERE "VASTLY DIFFERENT," AS IT DEPLOYED WITH FIVE TURNS AND RETRACTED WITH 20-25 TURNS. CONSEQUENTLY, THE LEAD WAS WITHDRAWN AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT WAS ATTEMPTED ON LEAD, BUT HELIX DEPLOYMENT AND RETRACTION WERE "VASTLY DIFFERENT". THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE INITIAL REPORT ALSO NOTED POSITIONING/FIXATION DIFFICULTY AND INFORMATION THAT THE HELIX DEPLOYED WITH FIVE TURNS AND RETRACTED WITH 20-25 TURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R