BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA

    MDR report key: 2945042 · Received February 6, 2013

    Report

    Report Number
    3007566237-2013-00378
    Event Type
    Death
    Date Received
    February 6, 2013
    Report Date
    January 22, 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 Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 435135, SERIAL# (B)(4), PRODUCT TYPE LEAD PRODUCT ID 435135, SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4): THE INITIAL MDR WAS FILED AS MFR REPORT # 3007566237-2013-00378. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE 3004209178. ADDITIONAL REVIEW INDICATES THE INFORMATION IN MFR REPORT # 3007566237-2013-02021 PERTAINS TO THIS MANUFACTURER¿S REPORT. ANY ADDITIONAL INFO WILL BE REPORTED IN THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED. THE PATIENT WAS IMPLANTED ON (B)(6) 2013. THE PATIENT HAD "CODED" AND WAS MOVED TO THE INTENSIVE CARE UNIT (ICU). THEN THE PATIENT WENT INTO CARDIAC ARREST AND DIED ON (B)(6) 2013. IT WAS STATED THAT THE PATIENT WAS "VERY HIGH RISK DUE TO HER CO-MORBIDITIES." THE DETAILS OF THE EVENT WERE NOT KNOWN, BUT IT APPEARED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF DEATH WAS ANOXIC BRAIN INJURY, SECONDARY TO CARDIAC ARREST. IT WAS STATED THAT THE CARDIAC ARREST WAS NOT LIKELY DUE TO THE STIMULATOR. THE DEATH WAS LIKELY SECONDARY TO RENAL FAILURE, DIABETES, ARRHYTHMIA, AND PRE-EXISTING DISEASE. NO FURTHER INFORMATION ON THE EVENT WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED HAS CONFIRMED DATE OF DEATH AS (B)(6), 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51015 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Death