BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4251449 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21613
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PUMP HAD DEHISCED AND THE PATIENT WAS BEING TAKEN BACK TO THE OPERATING ROOM TO EXPLANT THE PUMP. PER THE REPORTER, THE CATHETER WOULD BE LEFT IMPLANTED. IT WAS FURTHER REPORTED THE PATIENT WAS DIAGNOSED WITH AN INFECTION (B)(6) 2014. IT WAS UNKNOWN IF THE PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. THE PATIENT DID NOT HAVE MENINGITIS. THE CAUSE OF THE DEHISCENCE WAS THE PATIENT WAS GIVEN AN ABDOMINAL BINDER AND HAD ADJUSTED IT INCORRECTLY TO WHERE THE EDGE OF THE BINDER WAS RUBBING OVER THE PUMP INCISION SITE CAUSING EXTERNAL SKIN BREAKDOWN. IT WAS UNKNOWN IF THE INFECTION RESOLVED. THE PATIENT OUTCOME WAS NOTED AS ¿ALIVE AND WELL¿. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP RE PORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE LAST PUMP REFILL WAS ON (B)(6) 2014. THE PUMP WAS IMPLANTED IN THE PATIENT'S GLUTEAL AREA. THE PATIENT WAS WEARING THE BINDER DAILY. THE EDGE OF THE BINDER RUBBED RIGHT OVER THE GLUTEAL WOUND. SHE CONTINUED TO WEAR THE BINDER UNTIL THE DERMA BOND WORE OFF AND THE WOUND EDGES RUBBED APART. THE PATIENT WAS SEEN BY THE ER (EMERGENCY ROOM) WHO CALLED THE MANAGING PHYSICIAN STATING THAT THE PATIENT HAD WOUND DEHISCENCE. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2014 WITH AN OPEN WOUND WHICH WAS "CLEAN CONTAMINATED", BUT WITH THE SHINY PUMP VISIBLE THROUGH THE WOUND EDGES. HALF THE WOUND HAD OPENED UP, THE OTHER HALF LOOKED GOOD. THE NEED TO EXPLANT THE PUMP AT THE EARLIEST OPPORTUNITY WAS DISCUSSED WITH THE PATIENT. THE PATIENT WAS RATHER ALARMED AT THE PROSPECT OF LOSING THE PUMP AS IT HAD BEEN VERY HELPFUL TO HER PAIN SYNDROME. SHE ASKED IF IT COULD BE REPLACED IMMEDIATELY AND THE PHYSICIAN ADVISED HER THAT THEY SHOULD WAIT FOR THE WOUNDS TO HEAL COMPLETELY TO MAXIMIZE THE CHANCE THAT THE NEW PUMP WOULD NOT ALSO BECOME CONTAMINATED. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE PATIENT HAD INFECTION SYMPTOMS OF REDNESS, DRAINAGE, INCISIONAL WOUND OPENING, AND POCKET EROSION. A CULTURE OF THE DEVICE POCKET WAS OBTAINED. THE CULTURE RESULTS WERE "NO GROWTH". THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND A TOTAL DEVICE SYSTEM EXPLANT WAS DONE. THE PATIENT DID NOT EXPERIENCE DRUG WITHDRAWAL. THE PLAN AFTER IMPLANT WAS TO DO WOUND CARE AND LET THE POCKET CLOSE WITH SECONDARY INTENTION AND THEN REPLACE THE PUMP WITH A NEW POCKET IN A DIFFERENT LOCATION. THE PATIENT HAD MULTIPLE SKIN SORES OVER HER BACK WHICH SHE ATTRIBUTED TO INSECT BITES WHICH WERE COMPLICATING HER CARE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE HCP EXPLANTED BOTH THE PUMP AND THE CATHETER. MILKY WHITE SUBSTANCE PRESENT AT PUMP POCKET SITE, SO THE EXISTING CATHETER WAS EXPLANTED AT THAT TIME ALSO. THE CULTURES GREW OUT ¿NEGATIVE¿. THE PATIENT WAS SCHEDULED FOR NEW CATHETER AND NEW PUMP IMPLANT FOR TODAY BUT SURGERY WAS ABORTED WHEN DECUBITUS ULCER IN LEFT BUTTOCK (EXPLANTED PUMP POCKET SITE) LOOKED POTENTIALLY INFECTED AND NOT FULLY HEALED. PLAN FOR NEW PUMP AND NEW CATHETER AFTER DECUBITUS ULCER HEALS WITH PLACEMENT OF NEW PUMP INTO ABDOMEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE LAB RESULTS FROM THE CULTURE DONE ON (B)(6), 2 PLUS STAPHYLOCOCCUS SPECIES, COAGULASE. ON (B)(6), THE HEALTHCARE PROVIDER SPOKE WITH THE PATIENT IN REGARDS TO PLANNED FUTURE IMPLANT. AT THAT TIME NO DECISION WAS MADE. ON (B)(6), THE HEALTHCARE PROVIDER INSTRUCTED TO THE PATIENT TO FOLLOW UP ON POSSIBLE ANEMIC CONDITION WITH THEIR PRIMARY HEALTHCARE PROVIDER AND THE DECISION TO PROGRESS WITH PUMP IMPLANT WILL NOT BE MADE UNTIL ANEMIA CONDITION IS ADDRESSED. THE WOUND SITE WAS STILL HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736516 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention