BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3802355 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08783
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    November 8, 2010
    Report Date
    April 14, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP, MODEL # 8637-40, SN (B)(4), FOUND NO ANOMALY. THE PUMP WAS RECEIVED WITH AN EMPTY RESERVOIR AND LEFT RUNNING IN FLEX INFUSION MODE. INTERROGATION SHOWED A MOTOR STALL AND MOTOR STALL RECOVERY. .

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD ANOTHER SURGERY WHICH REPLACED THE PUMP AND THE CATHETER. PER THE REPORTER IT NEVER ¿WORKED PROPERLY¿ BUT IT ¿WORKED OK¿. THE PATIENT ENDED UP IN SEVERE PAIN. THE PATIENT WAS PARALYZED 8 YEARS PRIOR TO THIS REPORT AND FOR 4 YEARS, THE PATIENT HAD NO PROBLEM WITH THE PUMP. SIX MONTHS AFTER THE PUMP WAS IMPLANTED (IMPLANTED (B)(6) 2010), THE HEALTHCARE PROVIDER INCREASED THE MEDICATIONS AND THE PATIENT OVERDOSED. THE REPORTER WAS CONCERNED THAT SO MUCH MEDICATION WAS IN THE PUMP AND WANTED TO KNOW WHERE THE MEDICATION WOULD GO. THE REPORTER HAD TO CALL AN AMBULANCE (DATE NOT REPORTED) TO GET THE PATIENT BUT BECAUSE THE DOCTOR WAS NOT AT THE HOSPITAL, ¿THEY WOULD NOT TAKE THE TRANSFER¿. ON AN UNREPORTED DATE, THE PUMP DID NOT ALARM AND TWICE IT RAN OUT OF MEDICATION AND WAS EMPTY. WHEN THE PUMP WAS REFILLED, THE PATIENT WOULD HAVE NO PAIN FOR 4-5 DAYS, AND THEN HE WOULD BE IN EXCRUCIATING PAIN AND WAS ON ENOUGH NARCOTICS ¿TO KILL A HORSE¿. THE PATIENT NEVER HAD THERAPEUTIC EFFECT WITH THE PUMP THERAPY. WHEN A PUMP REFILL WAS PERFORMED (DATE NOT REPORTED), THE PATIENT WAS ¿OUT COLD¿ FOR 3-4 DAYS. THE PATIENT WOULD SLEEP. THEN THE PATIENT WOULD BE FINE. THE PATIENT WOULD GET OUT OF HIS CHAIR AND HE WOULD HAVE TO DO ¿EVERYTHING IN THAT WEEK¿BECAUSE HE CAN¿T SHOWER OR DO ANYTHING¿. FOR THE PAST 2 MONTHS, THE PATIENT WAS NOT GETTING ANY RELIEF FROM THE DISCOMFORT. BEFORE THIS TIME, THE PATIENT WAS GETTING RELIEF ¿A WEEK OUT OF A MONTH¿. THE ISSUES STARTED WHEN THE REPORTER WAS TOLD BY THE HCP WHO FILLED THE PUMP THAT THERE WAS SOMETHING WRONG WITH THE PUMP. THE PATIENT VISITED A NEUROSURGEON WHO SAID NOTHING WAS WRONG WITH THE PUMP AND THEY GOT INTO A BIG ARGUMENT. THE PATIENT AND REPORTER FELT THEY WERE STUCK IN THE MIDDLE AND WANTED TO HAVE THE PUMP CHECKED. THE PUMP¿S MALFUNCTIONING WAS A ¿CONSTANT BATTLE¿. A DYE TEST WAS PERFORMED AND THE REPORTER BELIEVED THE TEST WAS NOT SHOWING IF THERE WAS AN ISSUE WITH THE PUMP. THE REPORTER BELIEVED THE PATIENT MAY NEED TO HAVE THE PUMP REMOVED. THE PATIENT¿S CURRENT HCP DID NOT WANT TO EXPLANT THE PUMP, BUT THE REPORTER WANTED THE PUMP EXPLANTED. THE HCP REFUSED TO HAVE THE PATIENT AS A PATIENT ANYMORE BECAUSE THE HCP REFUSED TO CHANGE THE PUMP. THE PATIENT WAS LOOKING FOR A NEW HCP. AS OF THE DATE OF THE REPORT, THE PATIENT WAS HOSPITALIZED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THE PUMP WAS USED TO DELIVER CLONIDINE (OLD), BACLOFEN (CURRENT), LIDOCAINE (OLD) AND MORPHINE (CURRENT). ADDITIONAL INFORMATION LATER REPORTED AS FAR AS THE HCP¿S NURSE WAS AWARE, THE PATIENT HAS ONLY EVER HAD 2 PUMPS AND 1 CATHETER. THERE WAS NO INDICATION OF A 3RD PUMP. THE SECOND SURGERY WAS A REPLACEMENT OF THE CATHETER, NOT A REPLACEMENT OF BOTH THE PUMP AND CATHETER AS ORIGINALLY STATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS EXPLANTED AND REPLACED. THE LOGS SHOWED NO ISSUES. NO DIAGNOSTIC TESTING WAS PERFORMED. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF, ALSO REPORTED AS LOSS OF EFFECT OF SPASTICITY AND PAIN RELIEF. THE CAUSE OF THE EVENT HAD NOT BEEN DETERMINED. TO THE REPORTERS KNOWLEDGE, THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281695 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Hospitalization| R