BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2202015 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11258
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY (B)(4) THE FULL LEAD WAS RETURNED AND NO ANOMALIES FOUND. HOWEVER, IF WAS FOUND THAT THE INNER TUBING WAS KINKED/BUCKLED. THERE WAS BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD) AND BLOOD IN/ON HELIX/LOBE MECHANISM. IT WAS ALSO DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD LOW IMPEDANCE OUTSIDE THE BODY WITH THE HELIX COMPLETELY RETRACTED. THE LEAD WAS ATTEMPTED, BUT NOT USED. A NEW LEAD WAS IMPLANTED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other