BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3625023 · Received February 12, 2014

    Report

    Report Number
    3004209178-2014-02899
    Event Type
    Injury
    Date Received
    February 12, 2014
    Report Date
    January 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT APPARENTLY HAD MULTIPLE CO-MORBIDITIES AND HAD BEEN ATTENDED TO BY THEIR CURRENT MANAGING HEALTH CARE PROVIDER (HCP) FOR FOUR YEARS. THE PUMP HAD APPARENTLY BEEN ERODING THROUGH THE SKIN FOR FOUR YEARS. THE HCP INDICATED THE PATIENT HAD A LOCALIZED SKIN INFECTION PRESENT AT THE TIME OF SURGERY. THE PATIENT¿S POCKET HAD APPEARED REDDENED AND SWOLLEN WITH THE CAP (CATHETER ACCESS PORT) PROTRUDING VISIBLY OUT OF THE SKIN. THE PATIENT¿S WHITE BLOOD CELL COUNT WAS LOW AND THE HCP DID NOT SUSPECT A DEEP INFECTION OR SEPSIS. IT WAS REPORTED THE HCP HAD SUCCESS IN HEALING WOUNDS SIMILAR TO THE PATIENT¿S UTILIZING DEBRIDEMENT AND IMPLANTING ANTIBIOTIC IMPREGNATED BEADS WITH PACEMAKERS AND THEREFORE THE HCP WANTED TO TRY TO HEAL THE PATIENT¿S WOUND IN THE SAME FASHION. ADDITIONAL INFORMATION REGARDING POSSIBLE EVENTS WITH PACEMAKERS HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE OPTION OF REPLACING THE DEVICE SYSTEM WAS DISCUSSED; HOWEVER, THE HCP CHOSE TO PROCEED WITH THE SURGICAL INTERVENTION DESCRIBED DUE TO THE PATIENT¿S MULTIPLE CO-MORBIDITIES AND PREVIOUS SUCCESS WITH OTHER PATIENTS. DURING THE SURGERY, THE HCP OPENED THE PUMP POCKET, EXCISED THE TISSUE SURROUNDING THE PUMP, CURETTED THE ISSUE WITHIN THE POCKET TO OBTAIN VIABLE BLEEDING TISSUE, EXTENDED THE POCKET AND IMPLANTED BACTRIM ANTIBIOTIC IMPREGNATED BEADS. THE PUMP AND CATHETER WERE REMOVED FROM THE PATIENT¿S POCKET DURING THE SURGERY HOWEVER THEY WERE NEVER DISCONNECTED DURING THE REVISION. FIVE MILLILITERS OF DRUG WAS REMOVED FROM THE PUMP AND THEN 20ML OF MORPHINE WAS REFILLED. IT WAS NOTED THE PUMP RESERVOIR VOLUME WAS NOT UPDATED AT THE TIME OF SURGERY AND THAT NO CHANGES WERE MADE IN THE FLOW RATE, DELIVERY DOSE, ETC., AND AS A RESULT THE PUMP RESERVOIR VOLUME WAS TO BE UPDATED POST OPERATIVELY BY A HCP. THE PUMP WAS THEN TACKED DOWN WITHIN THE POCKET AND THE POCKET WAS CLOSED. DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD ALSO INCLUDED CHECKING THE PUMP LOGS, THE PUMP HAD BEEN INTERROGATED PRIOR TO THE SURGERY. ¿OTHER TESTS¿ PERTAINING TO THE PATIENT¿S MEDICAL STATUS WERE PERFORMED AS WELL; HOWEVER, THE SPECIFICS WERE NOT PROVIDED. PATIENT SYMPTOMS HAD ALSO INCLUDED DRAINAGE/INCISION WOUND OPENING. THE TYPE OF INFECTION WAS UNKNOWN TO THE REPORTER AND WHILE A CULTURE WAS OBTAINED OF THE DEVICE POCKET, THE TYPE OF ORGANISM CULTURED WAS NOT SPECIFIED. ADDITIONAL ACTIONS REQUIRED DUE TO THE EVENT OTHER THAN MEDICAL AND SURGICAL INTERVENTION AS REPORTED INCLUDE. HOSPITALIZATION. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY.¿ THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE DEVICE MANUFACTURER REPRESENTATIVE, WHILE SPEAKING WITH THE HCP PRIOR TO SURGERY, HAD THOUGHT HE SAID HE HAD BEEN TREATING THE PATIENT FOR FOUR YEARS FOR THE PROBLEM BUT IT ¿MUST HAVE BEEN¿ FOUR MONTHS DUE TO THE LENGTH OF TIME THE PATIENT HAD THE NEW PUMP IN PLACE. IN THE PRE-OPERATION CONVERSATION, THE HCP SPOKE ABOUT THE PATIENT¿S MULTIPLE CO-MORBIDITIES AND HIS THIN FRAME AS PROBABLE CONTRIBUTING FACTORS TO THE EROSION OF THE PUMP. THE PUMP APPEARED TO HAVE ERODED THROUGH THE MEDIAL ASPECT OF THE PUMP POCKET INCISION. THE DEVICE MANUFACTURER REPRESENTATIVE WAS UNSURE WHETHER THE LOCALIZED INFECTION DEVELOPED FIRST OR IF THE EROSION OF THE PUMP CAUSED THE LOCALIZED INFECTION. THE DEVICE MANUFACTURER REPRESENTATIVE SUSPECTED THE HCP HAD TAKEN CULTURES PRIOR TO SURGERY AS WELL DUE TO HIS CHOICE OF ANTIBIOTIC BEAD PREPARATION TO SPECIFICALLY INCLUDE BACTRIM; HOWEVER, THE REPRESENTATIVE HAD NO FURTHER INFORMATION OR MEDICAL RECORDS REGARDING THE TREATMENT OF THE PATIENT PRIOR TO THE RECENT SURGICAL INTERVENTION. THERE REPORTEDLY WAS NO INTERRUPTION IN THE PATIENT¿S THERAPY TO THE REPRESENTATIVE¿S KNOWLEDGE, THE PUMP CONTINUED TO RUN AND WAS NEVER DISCONNECTED. THE REPRESENTATIVE LEFT THE SURGICAL AREA IMMEDIATELY POST-OPERATION AND HAD HAD NO FOLLOW UP WITH THE PATIENT SINCE THE INTERVENTION. 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
    92712 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R