BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2122985 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07903
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), ALL INSULATORS WERE BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THERE WAS A TIP SEAL OBSERVATION AND THE LEAD APPEARED DAMAGED AT IMPLANT. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS CUT, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER TUBING HAD ENVIRONMENTAL STRESS CRACKING BREACH (NON-ELECTRICAL) AND THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH. THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE WITH NO CAPTURE. OVERSENSING WAS ALSO OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT DURING LEAD REPLACEMENT PROCEDURE, THE HELIX OF THE NEW LEAD RETRACTED AND WOULD NOT EXTEND. THIS LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. 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. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R 7231CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB