BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1921223 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12400
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 1, 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 Location
    CA
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED BEING TAKEN TO THE HOSPITAL BY AMBULANCE, AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS DUE TO A "FAULT WITH THE WIRE". MULTIPLE FOLLOW-UP ATTEMPTS YIELDED NO FURTHER INFORMATION. THE LEAD MAY HAVE BEEN 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. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB