BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3874482 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11628
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    December 16, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION - BASED ON ADDITIONAL INFORMATION RECEIVED IT HAS BEEN DETERMINED THAT THE DATE OF THIS REPORT AND DATE MANUFACTURER RECEIVED FOR THE INITIAL MDR SHOULD HAVE BEEN 12/16/2013. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE FIRST DOCUMENTATION OF 'FLIPPING' WAS ON (B)(6) 2012. THE HEALTHCARE PROVIDER WAS ABLE TO FLIP IT BACK AND REFILL IT UNDER FLUOROSCOPY. WHEN THE PATIENT WAS IN FOR A REFILL ON (B)(6) 2013, THE PUMP WAS FOUND FLIPPED. THE HEALTHCARE PROVIDER WAS UNABLE TO MANIPULATE IT FOR A REFILL SO ON (B)(6) 2013 THE PATIENT WENT TO THE OPERATING ROOM FOR A POCKET REVISION. AT THE NEXT REFILL, (B)(6) 2013, THE PUMP WAS FOUND FLIPPED AND THE HEALTHCARE PROVIDER WAS UNABLE TO REFILL SO ON (B)(6) 2013, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR ANOTHER REVISION. AT THE NEXT REFILL ON (B)(6) 2014, THE PUMP WAS FOUND FLIPPED AGAIN. THE HEALTHCARE PROVIDER WAS ABLE TO MANIPULATE AND REFILL THE PUMP. WHEN THE PATIENT WAS ASKED HOW OFTEN THE PUMP 'STANDS STRAIGHT UP' SHE REPORTED THAT '"IT DEPENDS". SOMETIMES, SHE MANIPULATES IT DOWN BUT SOMETIMES IT SEEMS 'IT DOES TO WANT TO MOVE' WITHOUT INCREASED PAIN SO SHE LETS IT BE, TRIES TO RELAX AND EVENTUALLY IT GOES BACK DOWN. IT WAS ALSO REPORTED THAT IT DOES NOT JUST HAPPEN WHILE SLEEPING AT NIGHT, IT ALSO OCCURS JUST ABOUT ANY TIME THE PATIENT BENDS OVER. THE PATIENT HAS NOT BEEN SCHEDULED FOR ANY ADDITIONAL PROCEDURES. THE PUMP WAS USED TO DELIVER 'PLAIN' MORPHINE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD A VERY LARGE PANNUS AND THE STITCHES HAD TORN FREE. AT THE REVISION, A DACRON POUCH WAS USED, ADDITIONAL NON-DISSOLVING SUTURES AND THE PATIENT WORE AN ABDOMINAL BINDER FOR A MONTH POST REVISION. EVERYTHING WAS GOOD UNTIL THE PATIENT QUIT WEARING THE BINDER. FLUOROSCOPY WAS USED FOR MEDICATION REFILLS DUE TO THE PATIENT'S OBESITY. THE PHYSICIAN DIDN'T HAVE ANY OTHER OPTIONS FOR THE PATIENT. THE PATIENT DOES GET PAIN RELIEF WITH THE MORPHINE AND DOES NOT TAKE ORAL MEDICATIONS. THE PHYSICIAN HAD NOT SEEN THE PATIENT SINCE (B)(6) 2014. THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT #3004209178-2014-00134 AND HAS BEEN DETERMINED TO BE A PART OF THIS EVENT: IT WAS REPORTED THAT THE PATIENT'S PUMP WAS MOVED AND RELOCATED 3 TIMES. THE DEVICE SYSTEM DELIVERED MORPHINE. ADDITIONAL INFORMATION RECEIVED REPORTED THEY WERE PLANNING ON REVISING THE PUMP BECAUSE IT WAS MOVING AROUND. IT WAS NOTED THE PATIENT WAS A "LARGER PATIENT", AND THEY WERE PLANNING TO IMPLANT IT SUB FACIALLY. THE HCP (HEALTHCARE PROFESSIONAL) WAS CONCERNED HE WOULDN'T BE ABLE TO REFILL IT WITH THE STANDARD NEEDLES. IT WAS REPORTED THE PUMP HAD FLIPPED IN THE PAST AND HAD BEEN REVISED AT LEAST ONCE. THEY STATED THEY USED A POUCH ON IT, BUT IT CONTINUED TO MOVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THEY WERE PLANNING ON REVISING A PUMP THAT WAS MOVING AROUND IN A LARGER PATIENT. IT WAS NOTED THEY WANTED TO IMPLANT IS SUB-FACIALLY AND THE HEALTH CARE PROVIDER (HCP) WAS CONCERNED IF THEY DID, THEY WOULD NOT BE ABLE TO REFILL IT WITH STANDARD NEEDLES. IT WAS NOTED THEY PUT A POUCH ON THE PUMP BUT IT CONTINUED TO MOVE (SEE MFG REPORT # 3004209178-2014-00134 FOR PREVIOUS FLIPPED PUMP AND REVISIONS). THE DRUG DELIVERED IN THE PUMP WAS UNKNOWN. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE FOR THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352599 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention