BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5180015 · Received October 27, 2015

    Report

    Report Number
    3004209178-2015-21515
    Event Type
    Injury
    Date Received
    October 27, 2015
    Date of Event
    July 7, 2015
    Report Date
    October 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-9, LOT# N159593, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, LOT# N166931007, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N162898, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF SYMPTOMS FOLLOWING PUMP REPLACEMENT/CATHETER IMPLANT ON (B)(6) 2015. SYMPTOMS INCLUDED INCREASED PAIN, HYPERTENSION (BLOOD PRESSURE WAS "200/100"), AND "FIDGETY." WHEN THE PUMP WAS CHANGED, THE CATHETER WAS ASPIRATED AND A FULL SYSTEM PRIME WAS DONE IN THE OPERATING ROOM (OR). THERE WAS A NEW CONCENTRATION OF MORPHINE IN THE NEW PUMP OF 1 MG/ML AT 0.99 MG/DAY, BUT THE POST-OPERATIVE DOSE WAS THE SAME DOSE THE PATIENT WAS ON PREVIOUSLY. DIAGNOSTIC RELATED TO POST-IMPLANT SYMPTOMS INCLUDE BEING SEEN BY A CLINICAL SPECIALIST; EVERYTHING APPEARED FINE, EXCEPT THE POST-UPDATE PUMP ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 71 MONTHS. ADDITIONAL INFORMATION WITH REGARD TO THE PROGRAMMED PUMP DOSAGE, SPECIFICALLY ANY PHYSICIAN ASSISTED (PA) BOLUSES OR PATIENT ADMINISTERED BOLUSES, HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE ADDED TO THE EVENT. THE PUMP WAS BEING USED TO DELIVER MORPHINE (UNKNOWN). (B)(6) 2015 - ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) INDICATED THE PATIENT CAME IN ON (B)(6) 2015 FOR A DOSE INCREASE BECAUSE SHE HAD NOT HAD ADEQUATE PAIN RELIEF AND WAS GOING THROUGH WITHDRAWAL SINCE THE REPLACEMENT ((B)(6) 2015). IT WAS NOTED THERE WAS FLUID AROUND THE PUMP POCKET AND THEY THOUGHT IT WAS A SEROMA. SINCE (B)(6) 2015 THE PATIENT HAD SWELLING AROUND THE PUMP. THEY ASPIRATED 125 ML OF CLEAR FLUID AND SENT IT FOR TESTING. THE PUMP WAS ONLY 20 ML AND WAS ONLY FILLED ONCE SINCE REPLACEMENT. THE FLUID TESTED POSITIVE FOR SOME MORPHINE. A CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2015 AS WELL AND IT SHOWED THE DYE WAS DELIVERING IN THE INTRATHECAL SPACE, BUT ALSO IN THE POCKET. THE PATIENT HAD A HEADACHE SINCE THE SURGERY ((B)(6) 2015). THE ASPIRATED VOLUME MATCHED WHAT WAS EXPECTED. THE PATIENT WOULD BE REFERRED TO THE EMERGENCY ROOM (ER) TO HAVE A REVISION DONE. THEY THOUGHT THE FLUID WAS CEREBROSPINAL FLUID (CSF) AND THOUGHT IT WAS TRACKING BACK DOWN OVER THE CATHETER INTO THE POCKET. THE REP WAS PRESENT AT THE PUMP REPLACEMENT AND AT THAT TIME THERE WERE NO ISSUES WITH THE CATHETER. THE REPORTERS OPINION WAS THAT THE CONNECTION BETWEEN THE NEW PUMP AND THE CATHETER WAS EITHER NOT DONE PROPERLY OR IT HAD COME UNDONE. THE PATIENT WAS RECEIVING MORPHINE 5 MG/ML (DOSE 0.9968 MG/DAY) VIA THE IMPLANTED PUMP. THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS NON-MALIGNANT PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER. IT WAS REPORTED THAT POCKET ASPIRATION, PUMP RESERVOIR VOLUME CHECK, CATHETER PORT ACCESS, AND A MYELOGRAM WERE PERFORMED. THE CONNECTOR ISSUE WAS CONFIRMED BASED ON CONTRAST LEAK IN THE POCKET WITH THE PUMP MYELOGRAM. THE PATIENT SYMPTOMS SINCE REPLACEMENT HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710869 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention