BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021881 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04258
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE REFILL AND THERE WAS DIFFICULTY ESTABLISHING TELEMETRY WITH THIS PATIENT'S DEVICE. NO ELECTROMAGNETIC INTERFERENCES WERE NOTED AND THE TELEMETRY HEAD WAS REPORTED TO BE PROPERLY POSITIONED. SEVERAL ATTEMPTS WERE MADE IN SEVERAL DIFFERENT ROOMS, WITH DIFFERENT PROGRAMMERS, AND BY DIFFERENT PEOPLE WITHOUT SUCCESS. A STOP PUMP COMMAND WAS ATTEMPTED AND THIS TOO WAS UNSUCCESSFUL. NO PUMP ALARMS WERE REPORTED. THIS PATIENT WAS VERY THIN WITH THIS PUMP VERY SUPERFICIAL AND REPORTED TO HAVE NOT FLIPPED. THE PUMP WAS LAST PROGRAMMED AND READ ON (B)(4) 2012. THE ESTIMATED REPLACEMENT INDICATOR (ERI) WAS 32 MONTHS AND HAD BEEN DECREASING APPROPRIATELY PER PREVIOUS SESSION REPORTS. OF NOTE, THE PATIENT DID HAVE A COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN APPROXIMATELY ONE MONTH PRIOR TO THE DATE OF THIS REPORT. HOWEVER, THE PATIENT HAD APPEARED TO RECEIVE ADEQUATE THERAPY SINCE THE SCAN AS THE PATIENT HAD NO REPORTED SYMPTOMS. IT WAS LATER REPORTED THAT ULTIMATELY ALL ATTEMPTS WERE UNSUCCESSFUL TO ESTABLISH TELEMETRY. THE PUMP WAS NOT REFILLED AND IT WAS REPORTED THAT THE PATIENT HAD ENOUGH DRUG IN THE PUMP TO LAST THROUGH THE END OF MARCH. THE PUMP WAS LIKELY TO BE REPLACED IN THE NEAR FUTURE. THIS DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT CAUSE OF THE EVENT WAS RELATED TO THE PUMP AND CATHETER. THE PUMP REPORTEDLY HAD PREMATURELY DEPLETED AND IT WAS UNKNOWN WHY THE PUMP STOPPED WORKING. BOTH THE PUMP AND CATHETER WERE SURGICALLY REMOVED. REPORTEDLY, THE CATHETER ¿IN THE SPINE WAS FINE¿ ALONG WITH THE CONNECTIONS. HOWEVER, APPROXIMATELY ¿A FOOT¿ OF THE CATHETER UNDER THE SKIN ON THE PATIENT¿S SIDE WAS EXTREMELY BRITTLE, CRACKED, AND DETERIORATING. THE PHYSICIAN HAD RETAINED THE CATHETER. THE SYMPTOM ASSOCIATED WITH THIS EVENT WAS REPORTED AS ¿PAIN CONTROL.¿ THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124077 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention