BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1925660 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13983
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INAPPROPRIATE SHOCKS. RIGHT VENTRICULAR IMPEDANCE WAS OVER 3000 OHM WHILE SIC COUNTER VALUE WAS 1700 AND THERE WAS NO CAPTURE. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD BUT WAS UNABLE TO PASS THE STYLET THROUGH THE SLEEVE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB