BEUDAMED
    FDA Adverse Event Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1863247 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11401
    Date Received
    October 9, 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
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE DISTAL CONDUCTOR WAS DISTORTED IN THE CONNECTOR AND HELIX TESTING WAS NOT POSSIBLE. THE DEFIBRILLATION CONDUCTOR WAS ALSO DISTORTED. THERE WAS BLOOD/BODY FLUID IN/ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND THE HELIX MECHANISM AND HELIX SLEEVEHEAD. THERE WAS DAMAGE FROM IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS DIFFICULTY EXTENDING THE HELIX "AFTER 1 EXTENSION"; HELIX MALFUNCTION IS SUSPECTED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS DIFFICULTY EXTENDING THE HELIX "AFTER 1 EXTENSION" AND HELIX MALFUNCTION SUSPECTED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS WERE 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 Other