BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 4241359 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03283
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE HCP REPORTED THAT AS OF 2014-(B)(6), THEY FOUND ANOTHER NOTE THAT THE PATIENT MAY HAVE HAD BACLOFEN IN THE PUMP, WHICH WAS WHAT THEY WERE ORIGINALLY TOLD AND HAD A PRINT OUT OF; BUT THEY WERE LATER TOLD BY ANOTHER HCP THAT THERE WAS NEVER ANY BACLOFEN IN THE PUMP. UPON DEVICE INTERROGATION, THE PUMP LOGS INDICATED THAT THE PUMP CONTAINED DILAUDID AND BUPIVACAINE AS OF 2013-(B)(6) AND 2014-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RUSHED TO A HOSPITAL BECAUSE THE WRONG MEDICATION WAS PUT IN HER DEVICE AND IT ¿ALMOST KILLED HER¿ BACK IN (B)(6) 2014. THE HEALTH CARE PROVIDER (HCP) HAD ORDERED THE WRONG MEDICATION AND ANOTHER HCP FILLED IT BUT WAS TOLD BY THE OTHER WHAT TO PUT IN THE PUMP AT THAT TIME. AS A RESULT, THE PATIENT WAS RUSHED UP TO ALMOST 1.5 HOURS FROM THE PATIENT¿S HOUSE WHEN IT HAPPENED. THEIR VITALS HAD BEEN DROPPING, THEIR SKIN WAS GETTING COLD AND ¿EVERYTHING¿ WAS SLOWING DOWN. THE PATIENT ¿ALMOST DIED¿. THE MEDICATION THAT WAS PUT IN THE PUMP WAS BACLOFEN AND IT WAS NOTED THE PATIENT COULDN¿T TAKE IT ORALLY BUT THE HCP TOLD THE PATIENT SHE COULD HAVE IT IN THE PUMP. THIS CAUSED THE ISSUE. PER A TELEMETRY STRIP, AS OF (B)(6) 2014, THE DEVICE DELIVERED DILAUDID, BUPIVACAINE AND BACLOFEN HOWEVER IT WAS NOT SPECIFIED IF THE DEVICE DELIVERED THESE MEDICATIONS AT THE TIME OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED INCLUDING WHAT INTERVENTIONS OR ACTIONS WERE TAKEN AND THE PATIENT¿S OUTCOME, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723734 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR