BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2051553 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05579
    Event Type
    Injury
    Date Received
    April 12, 2011
    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
    FL, 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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL OBSERVATIONS OF DEFIB CONDUCTOR DISTORTED, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY MELTED, ALL INSULATORS BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE AND BLOOD IN/ON HELIX MECHANISM (SLEEVE HEAD) AND IN/ON HELIX MECHANISM. ANALYST COMMENTED THAT HELIX WILL NOT EXTEND AT THIS TIME DUE TO DRIED BLOOD IN A DISTAL CONDUCTOR PREVENTING TORQUE TRANSFER WHEN THE IS-1 PIN IS ROTATED. IT CANNOT BE DETERMINED AT THIS TIME IF THIS CONTRIBUTED TO THE INABILITY OF THE HELIX TO FUNCTION CORRECTLY AT THE IMPLANT/EXPLANT ATTEMPT. (B)(4) DISTAL CONDUCTOR DISTORTED. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL OBSERVATIONS OF ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC) AND OUTER INSULATION COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RIGHT ATRIAL LEAD REVISION DUE THE UNDERSENSING AND LOW IMPEDANCE, THE CONNECTOR PIN OF THE RIGHT ATRIAL LEAD "GOT STUCK" IN THE HEADER OF THE DEVICE. THE CONNECTOR PIN WAS ABLE TO BE REMOVED. DURING THE PROCEDURE, THE RIGHT VENTRICULAR LEAD BECAME DISLODGED. THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED DUE TO ACCESS ISSUES. A REVIEW OF IMPLANT RECORDS INDICATES THAT THE SYSTEM WAS REPLACED FOUR DAYS LATER. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R