BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013415 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00935
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    November 14, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WIFE REPORTED THAT THE LEAD WAS REPLACED BECAUSE IT WAS "BAD." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN REPORTED THE LEAD WAS REPLACED DUE TO 2 SEPARATE IMPEDANCE SPIKES TO OVER 1000 OHMS. NO CONCLUSION CAN BE DRAWN IMPEDANCE, HIGH DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT THE LEAD WAS REPLACED BECAUSE IT WAS "BAD." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN REPORTED THE LEAD WAS REPLACED DUE TO 2 SEPARATE IMPEDANCE SPIKES TO OVER 1000 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB