BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 2890422 · Received December 30, 2012

    Report

    Report Number
    3007566237-2012-03155
    Event Type
    Injury
    Date Received
    December 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT'S SUICIDAL THOUGHTS WERE POSSIBLY RELATED TO A PRIALT OVERDOSE CAUSED BY A SUSPECTED PUMP FAILURE. THE ONSET OF THE LIFE-THREATENING SUICIDAL THOUGHTS WAS (B)(6) 2012, WHICH WAS THE SAME DAY THAT THE PATIENT WAS ADMITTED AS AN IN-PATIENT. IT WAS STATED THAT, WITH REGARD TO THE SUICIDAL THOUGHTS, PATIENT'S MEDICAL HISTORY HAD BEEN INCONSPICUOUS UNTIL THE EVENT. THE EVENT HAD ABATED AFTER DISCONTINUING THE USE OF PRIALT. AT THE TIME OF REPORT THE PATIENT WAS "RECOVERING" FROM THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT AS FAR AS THE REPORTER KNEW, THE PHYSICIAN HAD ONE PATIENT WITH A MEDTRONIC PUMP, AND THIS PATIENT WAS NOT TREATED WITH PRIALT. HE STATED THAT THE PATIENT IN THE REPORT HAD A GAS PROPELLED PUMP WITH CONSTANT FLOW, AND THAT HE HAD NOT HEARD ABOUT THIS EVENT OR THAT THERE WOULD BE A REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY DISCOVERED WHEN PUMP WAS DISCOVERED EMPTY, FOLLOWING PATIENT SYMPTOMS OF OVERDOSE AND SUICIDAL THOUGHTS. THE PATIENT HAD BEEN TREATED WITH PRIALT FOR A 'LONG TIME' SUFFERED FROM STRONG SUICIDAL THOUGHTS UNDER TREATMENT WITH PRIALT. DURING A CHECK OF THE PUMP, THE HEALTHCARE PROVIDER (HCP) REALIZED THAT THE PUMP WAS ALREADY EMPTY, ALTHOUGH THERE SHOULD HAVE BEEN EVEN MORE MEDICATION IN IT. SPECIFIC VOLUMES WERE NOT PROVIDED. THE HCP BELIEVED THE PUMP HAD A TECHNICAL FAILURE WHICH HAD LED TO AN OVERDOSE OF MEDICATION, AND SPECIFICALLY PRIALT. THE PUMP WAS REFILLED, THE PATIENT RECOVERED AND THE PUMP WAS TO BE REPLACED IN (B)(6) 2013, IN ORDER TO UNDERGO AN EXAMINATION. THE MEDICATIONS IN THE PUMP WERE PRIALT AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R