BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2930067 · Received January 25, 2013

    Report

    Report Number
    3004209178-2013-00982
    Event Type
    Injury
    Date Received
    January 25, 2013
    Report Date
    December 31, 2012
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT WAS NOT GETTING RELIEF FROM THE PUMP SYSTEM AND THE PUMP WAS 'NOT WORKING.' THERE HAD BEEN TROUBLE WITH THE 'TUBES' REGARDING HOW THEY WERE CONNECTED 'AND SO FORTH.' THE PHYSICIAN WAS GOING TO CONSIDER REPLACING THE 'TUBES' BUT WANTED TO WAIT UNTIL A WOUND IN THE PATIENT'S BUTT HEALED. IT WAS NOTED THAT THE LAST TIME THEY WENT THREE MONTHS 'WITHOUT SOMETHING COMING LOOSE THERE.' THE PATIENT HAD RELIEF FOR THE FIRST COUPLE OF YEARS BUT THEN AN X-RAY REVEALED THE CATHETERS DISPLACED. THE PHYSICIAN REATTACHED THE CATHETERS ABOUT A YEAR AGO BUT IT DIDN'T SEEM TO WORK AT ALL. THE PHYSICIAN HAD BEEN 'UPPING THE AMOUNT OF JUICE' INCLUDING AN INSTANCE A FEW MONTHS AGO BUT THE PATIENT'S FAMILY DIDN'T FEEL IT WAS GIVING THE PATIENT ANY RELIEF. THE FIRST CATHETER WAS 'LOST IN THERE' AND THE DOCTOR 'COULDN'T FIND IT OR SOMETHING.' IT WAS ALSO NOTED THEY COULDN'T EVEN GET A COMPLETE X-RAY TO FIND OUT WHERE THE TUBES WERE. THE PATIENT'S NEXT ALARM DATE WAS (B)(6). ON, (B)(6) 2012 THE PHYSICIAN INDICATED TO THE PATIENT 'THIS IS GOOD UNTIL (B)(6), AND THEN YOU'RE ON YOUR OWN.' IT WAS UNCLEAR TO THE PATIENT'S FAMILY WHAT THIS STATEMENT MEANT. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER HAD BEEN DISCONNECTED FOR A YEAR AND A FEW MONTHS. THERE WAS AN ATTEMPT TO TRY TO RECONNECT THE CATHETER, BUT IT "DIDN'T SEEM TO WORK". THE PATIENT HAD AN X-RAY DONE A FEW WEEKS AGO, BUT HAD NOT RECEIVED THE RESULTS. IT WAS NOTED IT WAS DIFFICULT TO GET A GOOD X-RAY SINCE THE PATIENT HAD CONTRACTIONS OF HIS LEGS. THE CATHETER HAD BEEN LEAKING SOMEWHERE. IT WAS THOUGHT THE PUMP WAS WORKING AND THE DOSE WAS INCREASED WHEN THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) PUT MORE FLUID IN THE PUMP A FEW WEEKS AGO. IT WAS SPECULATED THAT THE DRUG LEAKING WAS CAUSING THE PATIENT'S CONTRACTIONS AND TIGHTENING. IT WAS REPORTED THIS WAS THE SECOND TIME THERE WAS A DISCONNECT. THE FIRST TIME THE CATHETER COULD NOT BE FOUND. IT WAS REPORTED THE PATIENT HAD A SORE AND A POSSIBLE INFECTION IN HIS BODY FOR A YEAR OR SO THAT HAD TO BE CLEANED AND WAS HEALING GRADUALLY. THE PUMP HAD A "BAG" AND A KIND OF TUBE TO KEEP DRAINING THE SORE AND INFECTION TO HELP IT HEAL FASTER. THE HCP WAS WAITING FOR THE SORE TO CLEAR BEFORE DOING SURGERY. IT WAS ALSO REPORTED THE PATIENT WAS IN A WHEEL CHAIR AND GOT MANY "BUMPS" FROM LIFTING HIM UP AND DOWN INTO BED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THE CATHETER HAD BEEN DISCONNECTED FROM THE SPINAL CORD SINCE TWO YEARS AGO IN DECEMBER. IT WAS REPORTED THAT DURING A PREVIOUS REVISION, THE CATHETER COULD NOT BE FOUND SO IT WAS LEFT IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD AN "EXTRA TUBE" THAT CONFUSED PEOPLE ON X-RAY. THE EXTRA CATHETER WAS "CURLED UP". AN X-RAY WAS TAKEN AND DID NOT SHOW ANYTHING EXCEPT FOR THE "TUBE". CEREBROSPINAL FLUID WAS ATTEMPTED TO BE WITHDRAWN, BUT IT DIDN'T HAPPEN. IT WAS NOTED THE PATIENT HAD A SORE ON HIS BUTTOCK THAT HAD NOT BEEN CURED. IT WAS REPORTED THE DOSAGE WAS INCREASED AND IT WAS SPECULATED THAT HAVING MORE FLUID IN THE GENERAL SYSTEM COULD BE CAUSING THE "HARD TIME" GETTING THE SORE CURED. THE PATIENT HAD TOUGH SPASMS WITH A BROKEN LEG. THE PATIENT HAD AN "ORAL VACCINE" THAT SEEMED TO "SLOW THINGS DOWN" A LITTLE BIT. IT WAS ALSO REPORTED THERE WAS "DAMAGE" AND DRUG RUNNING INTO THE PATIENT'S SYSTEM, AND THE PATIENT LOST WEIGHT. THE PUMP HAD BEEN WORKING EXCEPT FOR THE CATHETER SITUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS DISPLACED "QUITE SOME TIME AGO". THE PATIENT HAD A FRACTURED LEG AND THE REPORTER DID NOT KNOW IF IT HAPPENED AT THAT TIME. THAT HAPPENED AT LEAST A YEAR PRIOR TO THIS REPORT. THE PATIENT WAS STILL GETTING SOME BACLOFEN FROM THE PUMP. THE HEALTHCARE PROVIDER (HCP) HAD BEEN REFILLING THE PUMP EVERY 3 MONTHS. THE REPORTER ALSO STATED THAT IT WAS HARD TO DETERMINE IF THE PATIENT WAS GETTING ANY BACLOFEN FROM THE PUMP. THE PATIENT ALSO TOOK ORAL BACLOFEN. IT WAS NOTED THAT THE PATIENT HAD A DECUBITUS ULCER ON HIS BUTTOCKS, WHICH WAS NOT COMPLETELY HEALED. THE HEALTHCARE PROVIDER (HCP) INSISTED THAT THE PATIENT MADE A DECISION BY APRIL OR MAY ABOUT WHAT HE WANTED TO DO WITH THE PUMP, SINCE THE PATIENT WAS NOT SURE IF HE WANTED IT REMOVED OR REPLACED. THE SURGEON STATED THAT HE DID NOT WANT TO REMOVE THE PUMP UNTIL THE DECUBITUS ULCER WAS HEALED AND CLOSED. THE PATIENT'S FRIEND OR FAMILY MEMBER THOUGHT THAT SURGERY WOULD BE PHYSICALLY HARD ON THE PATIENT. THE REPORTER WANTED TO KNOW IF IT WOULD BE OKAY TO LEAVE THE PUMP IN THE BODY. THE PUMP WAS NOT ALARMING. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED INCREASED TONE. DUE TO THE DECUBITUS, THERE WAS NO ONE WILLING TO REPLACE THE PUMP. AT THE TIME OF THIS REPORT, THE PATIENT HAD POORLY CONTROLLED TONE WITH ASSOCIATED INCREASED PAIN. THE PATIENT WAS TAKING ORAL BACLOFEN AND THE HCP WAS CONSIDERING VALIUM. THE PUMP WAS TO REACH END OF LIFE (EOL) IN LESS THAN FIVE MONTHS. IT WAS NOTED THAT THE PATIENT WAS ALSO TAKING FLOMAX AT THE TIME OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT CALLER WANTED TO HAVE THE DOSAGE REDUCED AND WANTED A 2ND OPINION. IT WAS NOTED THAT THE PUMP HAD NOT WORKED PROPERLY FOR 3 YEARS. IT WAS REPORTED THAT BACLOFEN WAS IN THE PUMP. IT WAS NOTED THAT THE CATHETER WAS CURRENTLY DISCONNECTED AT THE TIME OF REPORT. IT WAS REPORTED THAT IT BECAME DISCONNECTED ABOUT 2 YEARS PRIOR. IT WAS NOTED THAT THE CATHETER WAS KINKED. IT WAS REPORTED THAT AN X-RAY IN (B)(6) 2012 SHOWED THE KINK. IT WAS NOTED THAT THEY HAVE NOT TRIED TO RECONNECT THE CATHETER. IT WAS REPORTED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) WAS NOT WILLING TO REDUCE THE DOSE AND WAS TRYING TO SCHEDULE SURGERY IN 3 MONTHS AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35671 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention