BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3242746 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12165
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3116 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SN # (B)(4)) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE INS WAS AT THE NORMAL END OF LIFE AND THERE WAS NO TELEMETRY OR OUTPUT. VISUAL INSPECTION FOUND THAT THE EPOXY BONDS WERE BROKEN ON BOTH BATTERY TERMINALS. DESTRUCTIVE ANALYSIS REVEALED THAT THE BATTERY DID NOT EXPERIENCE AN INTERNAL PROBLEM. NO PROBLEMS WERE FOUND WITH THE BATTERY.

    Description of Event or Problem · 1

    IT WAS ALSO NOTED THAT THIS WAS A SIMPLE BATTERY REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT SOME RELIEF BUT IT GOT WORSE. IT WAS NOTED THEY FOUND ¿PUT WAS NOT WORKING.¿ THE BATTERY WAS REPLACED ON (B)(6) 2013. BATTERY LIFE EXPECTED 8.2 MONTHS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING FINE. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343338 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention