BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1855054 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09261
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    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. EVALUATION SUMMARY : (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE OUTER INSULATION WAS BREACHED WITH AN ENVIRONMENTAL STRESS CRACK. THE DISTAL AND DEFIBRILLATION CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON SEVERAL CONDUCTORS, AND THE INNER TUBING WAS KINKED/BUCKLED. THE OUTER INSULATION HAD A COSMETIC CUT, BREACHED CUT, AND COSMETIC DEPRESSION. ADDITIONALLY, THERE WAS BLOOD IN/ON THE SLEEVE HEAD OF THE HELIX MECHANISM AND ON THE HELIX MECHANISM.

    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 LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD WAS OVERSENSING CAUSING INAPPROPRIATE HIGH VOLTAGE THERAPY SHOCKS. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R