BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3832803 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09618
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    December 13, 2013
    Report Date
    May 3, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT WHEN THE PATIENT WOULD LIE ON HER BACK FOR A CERTAIN PERIOD OF TIME, SHE GOT A BIG SEROMA/BUMP ON HER BACK. THIS HAD BEEN HAPPENING SINCE IMPLANT. ON (B)(6) 2014, THE PATIENT FELL AND SHATTERED 3 RIBS ON HER RIGHT SIDE. AFTER THIS THE PATIENT NOTICED THAT SHE STARTED TO EXPERIENCE WITHDRAWAL. THE PATIENT STARTED TO FEEL INTENSE OPIATE WITHDRAWAL IN (B)(6) OF 2014. THE PATIENT DID NOT HEAR ANY ALARM. THE PUMP WAS DELIVERING FENTANYL AND DILAUDID AT THE TIME. THE PATIENT KNEW THAT SHE WAS IN WITHDRAWAL BECAUSE SHE STARTED HAVING SUICIDAL THOUGHTS; THE CHILLS; SHE COULDN'T EAT OR SLEEP; SHE WAS DIAPHORETIC; AND SHE WAS HYPERTENSIVE WHEN NORMALLY SHE WAS MORE HYPOTENSIVE. THE PATIENT STARTED SEEING A PSYCHIATRIST WHO PRESCRIBED SEROQUEL WHICH HELPED. A DYE STUDY WAS DONE WHEN SHE WAS LYING ON HER BACK. THE HCP (HEALTHCARE PROVIDER) COULDN'T ASPIRATE ANY MEDICATION "FROM THE PUMP". THE HCP PUT DYE IN AND NOBODY COULD SEE THE CATHETER. THE CATHETER MIGRATED. THE HCP "KNOCKED HER DOWN TO (B)(4) THE DAY OF THE DYE STUDY". THE HCP WANTED HER IN THE OR (OPERATING ROOM) AS SOON AS POSSIBLE, BUT THE PATIENT ENDED UP WAITING 6 WEEKS. A REVISION WAS DONE IN (B)(6) OF 2014. WHEN THE PATIENT WENT IN FOR THE REVISION, SHE WAS ON HER SIDE. ANOTHER DYE STUDY WAS DONE WHEN SHE WAS ASLEEP AND THE "CATHETER WAS THERE", "THEY COULDN'T FIGURE OUT WHY THEY NEVER SAW THE CATHETER WHEN THEY DID THE DYE STUDY". "THEY REALIZED THAT THE CATHETER WAS WHERE IT'S SUPPOSED TO BE". THE PATIENT WAS WONDERING IF "IT'S THE ORIFICE THAT CAME LOOSE WHEN SHE BROKE HER RIB� AS OF THE DATE OF THIS REPORT, THE PATIENT HAD NUMBNESS IN HER LEGS AND SOMETIMES SPORADICALLY THEY WOULD STOP WORKING AND SHE WOULD FALL DOWN. THREE DAYS PRIOR TO THIS REPORT, SHE FELL IN THE SHOWER ON HER SPINAL PROCESS AND HAD A TREMENDOUS HEMATOMA ON IT. IT WAS REPORTED THAT INITIALLY THE BATTERIES WERE IN BACKWARDS IN THE PTM (PERSONAL THERAPY MANAGER). THE PATIENT STATED THAT WHEN SHE GAVE HERSELF A BOLUS WITH THE PTM SHE DIDN'T FEEL A CHANGE IN HER PAIN. SHE NEVER HAD A THERAPEUTIC EFFECT WHEN SHE GAVE HERSELF A BOLUS. SHE DID SEE THE CONFIRMATION SCREEN ON THE PTM STATING THE BOLUS WENT THROUGH, BUT DIDN'T NOTICE A CHANGE IN THE PAIN. IT HAD BEEN THIS WAY "SINCE SHE GOT THE PUMP". THE PATIENT'S PAIN STARTED AT T4 AND T5 ALL THE WAY DOWN HER LEGS; THE PATIENT STATED SHE HAD RADICULOPATHY, HER LEFT LEG WAS NUMB, AND SHE HAD ARACHNOIDITIS. THE PATIENT SAW HER HCP THE DATE OF THIS REPORT AND GOT A "(B)(6) INCREASE ON THE PTM". THEY WERE PLANNING TO "REDUCE THE SALINE IN HER PUMP AND ADD MORE MEDICATION SO SHE ONLY HAD TO BE SEEN 4 TIMES A YEAR". PRIOR TO HAVING THE PUMP IMPLANTED, THE PATIENT WAS TAKING 16 OXYCONTIN (80MG) EVERY DAY ON TOP OF 10 MG OF METHADONE, 8 SOMAS, 6 NAPROXEN, AND 1800 MG OF GABAPENTIN WHICH HAD AFTER YEARS CAUSED HER TO DEVELOP PROBLEMS WITH HER LIVER. AFTER IMPLANT, THE PATIENT WAS OFF ALL OF THAT; SHE WAS DOWN TO 4 IMMEDIATE RELEASE OXYCODONE (30 MG) A DAY. THE PATIENT STATED THAT SHE "IS REALLY HAPPY WITH THE PUMP". THE DEVICE SYSTEM WAS CURRENTLY DELIVERING FENTANYL (750.0 MCG/ML AT 225.26 MCG/DAY) AND DILAUDID (12.0 MG/ML AT 3.604 MG/DAY). THE NEXT TIME, THEY WANTED TO ADD BACLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PARANOID ABOUT EVERYTHING BECAUSE SINCE IMPLANT SHE HAD BEEN HAVING ALL SORTS OF PROBLEMS WITH THE IMPLANT. THE PATIENT HAD A PUMP REVISION ON (B)(6) 2014. THE PATIENT¿S PUMP WAS REFILLED ON (B)(6) 2014 AT 3:30 AND SHE WAS GIVEN THE PERSONAL THERAPY MANAGER (PTM) AT THAT TIME. THE ESTIMATED ELECTIVE REPLACEMENT INTERVAL WAS 76 MONTHS. THIS DEVICE SYSTEM DELIVERED FENTANYL AND DILAUDID. 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
    311060 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention