BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND II

    MDR report key: 3740968 · Received April 10, 2014

    Report

    Report Number
    2647346-2014-00022
    Event Type
    Injury
    Date Received
    April 10, 2014
    Report Date
    January 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LWO
    PMA / PMN Number
    P850051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: (B)(4) IMPLANTABLE TISSUE VALVE, (B)(6) 1996. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY ROOM WHERE IT WAS NOTED THAT THE DEVICE WAS COMPLETELY DEAD AND NO TELEMETRY COULD BE ESTABLISHED. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THERE WAS LOW IMPEDANCE AND HIGH THRESHOLD, AND FLUOROSCOPY SHOWED THAT THE LEAD HAD DISLODGED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218933 LEGEND II PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE LWO MDT PUERTO RICO OPERATIONS CO, MED REL 8424

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R 4024-58 IMPLANTABLE PACING LEAD