BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1854869 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09284
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. EVALUATION SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT THE THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE DISTAL CONDUCTOR WAS FRACTURED DUE TO OVERSTRESS. THE ANALYST COMMENTED THAT THE DISTAL CONDUCTOR HAD BEEN OVER-RETRACTED AND FRACTURED IN THE CONNECTOR. CORRECTED DATA - ADVERSE EVENT FLAG, EXPLANT DATE, MFG. DATE.

    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

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS DIFFICULTY TO IMPLANT MAINLY DUE TO A FAULTY HELIX. HOWEVER, THE PHYSICIAN WAS ABLE TO PLACE THE LEAD WITH THE HELIX FULLY EXTENDED, BUT SUBSEQUENTLY, VERY LOW R-WAVE WAS OBSERVED. CONSEQUENTLY, THE PHYSICIAN INTENTIONALLY DISLODGED THE LEAD AND MANAGE TO RETRACT THE HELIX. HOWEVER, DURING REPOSITIONING OF THE LEAD, THE HELIX WOULD NOT EXTEND AFTER 20 TURNS. THEREFORE, THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEAD. 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 ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention