BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3003801 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03690
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED "NO ANOMALY" AND THE FOLLOWING: "THE RETURNED INS SERIAL NUMBER (B)(4) IS FUNCTIONALLY OK. THE DEVICE HAS TELEMETRY WITH THE 8840 CLINICIAN PROGRAMMER AND THE INITIAL REVIEW (IR) SHOWS PROGRAMMED AMPLITUDE OF 7 VOLTS AND 573 HOURS OF USE."

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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'S DEVICE WAS REPLACED. ABOUT A WEEK LATER IT WAS REPORTED THAT THE DEVICE COULD NOT BE READ AFTER THE LEADS WERE HOOKED UP DURING SURGERY. NO ATTEMPT TO INTERROGATE THE DEVICE PRIOR TO IMPLANT WAS PERFORMED. FOUR DAYS LATER IT WAS REPORTED THAT THE DEVICE THAT COULD NOT BE READ WAS REPLACED AND THE NEW DEVICE WAS IMPLANTED AND PROGRAMMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107274 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1