BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2202027 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11259
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 3, 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
    ES
    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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE CONNECTOR PIN WAS PULLED OUT/OFF. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS STRETCHED AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE ANALYZER CABLE INTERFACE (ACI) ADAPTER WAS PUSHED DOWN ONTO THE LEAD TOO FAR AND CAUGHT ON THE CONNECTOR PIN. DURING THE PROCEDURE, WHEN IT WAS ATTEMPTED TO REMOVE THE ACI THE CONNECTOR PIN SEPARATED FROM THE CONNECTOR. THE STYLET WAS NOT STUCK IN THE LEAD. THE ACI WAS REMOVED DURING ANALYSIS.

    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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE CONNECTOR PIN WAS PULLED OUT/OFF. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS STRETCHED AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE ANALYZER CABLE INTERFACE (ACI) ADAPTER WAS PUSHED DOWN ONTO THE LEAD TOO FAR AND CAUGHT ON THE CONNECTOR PIN. DURING THE PROCEDURE, WHEN IT WAS ATTEMPTED TO REMOVE THE ACI THE CONNECTOR PIN SEPARATED FROM THE CONNECTOR. THE STYLET WAS NOT STUCK IN THE LEAD. THE ACI WAS REMOVED DURING ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE VENTRICULAR LEAD WAS IMPLANTED FIRST AND THE MEASUREMENTS WERE OK. AFTER THE ATRIAL LEAD WAS SUTURED THE VENTRICULAR LEAD MEASUREMENTS WERE TAKEN AGAIN AND THE R-WAVE MEASURED LOW. THE LEAD WAS REPOSITIONED AND FIXED. WHEN THE PHYSICIAN TRIED TO REMOVE THE STYLET, IT COULD NOT BE REMOVED. THERE WAS GREAT RESISTANCE AND THE LEAD WAS BROKEN AT THE CONNECTOR AREA. THE LEAD WAS NOT IMPLANTED AND ANOTHER 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