BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3100706 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07406
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 19, 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: 8731 SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8835 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN (B)(6) 2012 THAT THE PATIENT HAD WITHDRAWAL SYMPTOMS, INCLUDING SEVERE DIARRHEA AND WEIGHT LOSS, AS A PUMP REFILL WAS MISSED WHEN HE WAS UNABLE TO DRIVE TO THE HEALTHCARE PROVIDER'S (HCP) OFFICE, DUE TO A BROKEN LEG. THE PATIENT INITIALLY STATED REGARDING THE PUMP ALARM AND EVENT, "IT WENT DRY AND I COULDN'T HEAR IT". THE HCP REPORTED BACK IN (B)(6) 2012, THAT THERE WAS NO PROBLEM WITH THE PUMP, BUT THAT THE PATIENT HAD LAPSED FROM THE INTRATHECAL MEDICATION, AS HE HAD NOT FOLLOWED WITH THE SCHEDULED REFILL OF THE PUMP. IN ADDITION, THE HCP INDICATED THAT THE PUMP WAS TAPERED TO A MINIMAL RATE DUE TO POOR COMPLIANCE WITH REFILLS, AND EVENTS ASSOCIATED WITH THE PATIENT'S ABILITY TO COMPLY WITH THE MEDICAL DEVICE. IT WAS LATER REPORTED ON (B)(6) 2013, THAT THE PUMP WAS STILL "TURNED DOWN WAY LOW", AS THE PATIENT HAD LET THE PUMP RUN OUT BACK WHEN THE BROKEN LEG OCCURRED. THE PATIENT WAS LOOKING FOR A NEW PROVIDER TO MANAGE THE PUMP NEEDED TO FIND SOMEONE "REAL QUICK". IT WAS THEN LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD DISSATISFACTION WITH THE HCP'S MANAGEMENT OF THE PATIENT'S PAIN, AND HE ATTEMPTED SUICIDE IN (B)(6) 2012 DUE TO THE PAIN ISSUES. THE PATIENT REFERRED BACK TO HAVING INITIALLY EXPERIENCING WITHDRAWAL DUE TO A BROKEN LEG AND INABILITY TO TRAVEL TO THE HCP OFFICE IN (B)(6) 2012. THE PATIENT BROKE HIS LEG "SEVERELY" AND WAS IN A WHOLE LEG CAST AND COULD NOT GET IN A VEHICLE, THUS THE PUMP RAN OUT AT THAT TIME. PER THE PATIENT'S ACCOUNT, FOLLOWING THE MISSED REFILL, THE HCP HAD CHANGED THE PATIENT'S PAIN PUMP TO THE "LOWEST SETTING" WHEN HE DID REFILL IT EVENTUALLY, AS THE PATIENT HAD TO "START ALL OVER" AS HE HAD BEEN THROUGH WITHDRAWAL. ON (B)(6) 2013, THE PATIENT REPORTED "THIS HAS BEEN GOING BACK TO (B)(6), AND I'M STILL GETTING THE SAME AMOUNT OF MEDICATION". THE HCP WOULD NOT TURN THE PUMP BACK UP. THE PATIENT THEN INDICATED THAT HE ATTEMPTED SUICIDE ON (B)(6) 2012, LEAVING A LETTER STATING "HE COULD NOT DEAL WITH THE PAIN FROM THE NEUROPATHY AND A SEVERE BACK", TO WHICH THE PATIENT STATED "DOES THAT NOT TELL YOU THAT THE PAIN MANAGEMENT DOCTOR IS FAILING TO CONTROL MY PAIN, AND I WOULD BE WILLING TO TAKE MY LIFE OVER NOT BEING ABLE TO DEAL WITH PAIN". THE PATIENT HAD TAKEN OVER 200 PILLS AND LEFT A LETTER REGARDING THE PAIN, AND NOTED BEING UPSET AT BEING STUCK IN THE HOUSE AND UNABLE TO WALK BECAUSE OF THE PAIN. FOLLOWING THE SUICIDE ATTEMPT, THE PATIENT NOTED BEING UNCONSCIOUS AND IN THE HOSPITAL FOR 8 DAYS. PER THE PATIENT, THE HCP INDICATED THAT "WHERE THE PUMP'S AT" WOULD ONLY HELP THE PATIENT'S BACK, AND WOULD NOT ADDRESS THE DIABETIC NEUROPATHY. IN ADDITION, THE HCP WOULD NO LONGER PRESCRIBE THE SAME ORAL MORPHINE DOSE AS WAS PRESCRIBED PRIOR TO THE WITHDRAWAL. FOLLOWING THAT CHANGE WITH THE HCP, THE PATIENT INDICATED "THAT'S WHEN I DECIDED THIS ISN'T NO KIND OF LIFE". THE PATIENT NOTED DISSATISFIED WITH THE PUMP MANAGEMENT HCP, AND WANTED A NEW HCP. THE PATIENT INDICATED THAT THE HCP OFFICE STARTED OUT VERY SMALL, AND AT THE TIME OF REPORT, THERE WERE SEVERAL PROVIDERS IN THE OFFICE WHICH MADE COMMUNICATION WITH THE HCP DIFFICULT. THE PATIENT HAD TO DRIVE 60 MILES TO SEE THE HCP. THE PATIENT ALSO NOTED THAT HE NO LONGER FELT COMFORTABLE WITH THE HCP, AND THE HCP WAS NO LONGER CONTROLLING THE PAIN. THE PATIENT FELT HE WAS SUFFERING DUE TO THE DIABETIC NEUROPATHY, WHICH THE HCP INDICATED THE PUMP WILL NOT CONTROL AS IT IS ONLY TO CONTROL THE BACK ISSUES. THE PATIENT FURTHER STATED "I DID TRY TO COMMIT SUICIDE ON (B)(6) AND MY SUICIDE LETTER SAYS, I'M (B)(6), MY BODY IS WORE OUT, I CAN'T TAKE THE PAIN NO LONGER. MY PAIN MANAGEMENT DOCTOR IS NOT CONTROLLING MY PAIN". THE PATIENT INDICATED HE SAW THE HCP THE WEEK PRIOR TO (B)(6) 2013, BUT THE HCP INDICATED, THE PATIENT HAD TO HAVE A PSYCHIATRIC REPORT BEFORE THEY WOULD BE WILLING TO TURN UP THE PUMP OR GIVE THE PATIENT ANY MEDICATION. THE PATIENT INDICATED, HE NEVER SAW A PSYCHIATRIST WHEN IN THE HOSPITAL WHEN HE WOKE UP FOLLOWING THE SUICIDE ATTEMPT, AND "DID NOT BELIEVE IN A PSYCHIATRIST". THE PATIENT LATER SAID, HE HAD SEEN ONE IN THE HOSPITAL FOR 5 MINUTES BUT NEVER DID SEE THEM AGAIN, THUS IT WAS UNCLEAR IF THERE WAS A VISIT AT THE TIME OF HOSPITALIZATION. THE PATIENT LATER INDICATED THAT THE HCP SUGGESTED THAT THE PATIENT HAVE THE PUMP TURNED OFF OR TAKEN OUT AND TO GO BACK ON MEDICATION. THE PATIENT WAS PLANNING TO PROCEED WITH ATTEMPTS TO ESTABLISH CARE WITH A NEW HCP IN ORDER TO "TAKE CARE OF THIS PROBLEM", OR WOULD "JUST HAVE IT SCHEDULED TO TAKE THE PUMP OUT AND DO AWAY WITH IT", AS THE PATIENT HAD "EXCELLENT CONTROL WHEN THE PUMP WAS WORKING". IT WAS LATER REPORTED ON (B)(6) 2013, THAT THE PATIENT WAS VERY DISGUSTED AND WOULD PROBABLY JUST HAVE TO HAVE TO PUMP TAKEN OUT, AS HE WAS UNABLE TO FIND AN HCP TO TAKE CARE OF IT. ON (B)(6) 2013, IT WAS REPORTED BY THE HCP THAT THE PATIENT WAS UNABLE TO MAINTAIN HIS RESPONSIBILITY OF THE PUMP AND HAD MISSED APPOINTMENTS, AND "SEVERAL ATTEMPTS TO LOCATED PT". ON (B)(6) 2012, THE PUMP WAS SET TO A MINIMAL RATE DUE TO ALARM STATUS AND MISSED APPOINTMENTS. THE PATIENT WAS LATER INCARCERATED AND THEN HOSPITALIZED IN (B)(6) 2012 FOR SUICIDE ATTEMPT. THE PUMP WAS USED TO DELIVER DILAUDID AND MARCAINE. 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
    201758 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| L