BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3240685 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12087
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 27, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# J10840R09, IMPLANTED: 2001 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED INFORMATION: CONCLUSION CODE NO LONGER APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TO HAVE AN EMERGENT MRI DONE AS THE PATIENT STARTED HAVING SEIZURES. THE REPORTER INDICATED THERE WAS A SUSPECTED PUMP ISSUE, THUS THE PATIENT WAS UNDERGOING AN MRI OF THE BRAIN. IT WAS NOTED THE PATIENT JUST HAD THE PUMP PLACED THE WEEK PRIOR TO THE REPORT DATE. THE PUMP DEVICE WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE PATIENT WAS NOT HAVING RESULTS WITH THE PUMP. PER THE PATIENT AFTER THE PUMP CHANGE IN (B)(6) 2013 THE PATIENT GOT VERY SICK. THE PATIENT "LOST HER MEMORY" AND "WASN'T FUNCTIONING". THE PATIENT STATED THAT THEIR HEALTHCARE WORKERS DIDN'T THINK THE PATIENT WAS "EVER COMING BACK" STATING THAT IT WAS ALL FROM CHANGING THE PUMP. THE PHYSICIAN STATED IT WAS A SEIZURE AND ANOTHER PHYSICIAN STATED THE PATIENT HAD ENCEPHALITIS RIGHT AFTER THE PUMP WAS CHANGED. THE PATIENT STATED HER ENCEPHALITIS HAS BEEN RESOLVED (BODY FINALLY READJUSTED). THE SAME DAY THE PATIENT HAD THE PUMP PUT IN THE PATIENT WAS THROWING UP AND DISORIENTED AND WENT BY AMBULANCE THE NEXT DAY. THE PATIENT WAS IN THE HOSPITAL A NUMBER OF DAYS AND DOESN'T REMEMBER ANYTHING OTHER THAN BEING PUT ON A STRETCHER. THE PATIENT DIDN'T EVEN KNOW ABOUT GOING TO REHAB, AND AFTER A WEEK IN REHAB CAME HOME AND COULDN'T FUNCTION. THE PATIENT STAYED HOME AND SUFFERED AT HOME. THE PATIENT WAS PROBABLY A WEEK IN THE HOSPITAL BEFORE THEY PUT HER INTO REHAB. THE PATIENT WAS TRYING TO TELL THEIR HEALTHCARE PROVIDER THAT THE MUSCLE RELAXER MEDICATION IN THE PUMP WASN'T WORKING AND WAS GOING TO SEND A LETTER AND REMINDED THE HEALTHCARE PROVIDER AT THE LAST VISIT. PER THE PATIENT THIS PUMP WAS SMALLER AND WAS RIGHT BELOW THEIR WAIST AND "FLOATS", MEANING IT GOES BACK AND FORTH. IF THE PATIENT REACHES FOR SOMETHING IT IS IN THE WAY. IF THE PATIENT SITS AND DOESN'T MOVE THE PATIENT WAS "OK" WITH THEIR PAIN BUT IF THE PATIENT TRIES TO DO SOMETHING SHE HAS SHOOTING PAIN IN HER SPINE AND HAD TO SIT DOWN. THE PATIENT HAS ALWAYS HAD THIS PAIN BEFORE THE PUMP. THE PATIENT'S SPINE PHYSICIAN TRIED TO HAVE THE PATIENT GO TO ANOTHER PHYSICIAN AND THE PATIENT FEELS "STUCK". THE PATIENT'S HISTORY INCLUDED THE PATIENT JUST HAD ROTATOR CUFF SURGERY AND HAS A SCREW IN THERE. THE PATIENT JUST GOT OUT OF THE BRACE AND WAS STILL IN THERAPY. THE PATIENT STATED THE PUMP WAS NOT AFFECTED BY THE MRI'S, THE PATIENT HAS HAD 2 MRI'S THE PATIENT HAD AN MRI BECAUSE OF SOMETHING IN THEIR BREAST NOW (NOT RELATED TO THE PUMP) AND WENT TO A SURGEON. THE PATIENT ALSO SPINAL SURGERY PRIOR TO THE PUMP WHERE CEMENT WAS PUT INTO THEIR SPINE AND CAN'T HAVE IT REMOVED OR IT WOULD PARALYZE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340099 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| O