BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4031521 · Received August 22, 2014

    Report

    Report Number
    3004209178-2014-15786
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP HAD BEEN ¿DOING WELL UNTIL NOW¿. THE PATIENT FELT THERE WAS ¿SOMETHING GOING WRONG WITH THE PUMP¿. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) REPORTEDLY SAID THE PUMP ¿SEEMS TO BE OVERMEDICATING¿ THE PATIENT. THE PATIENT HAD BEEN ¿DOING GOOD¿ UNTIL THIS POINT, BUT THEY ¿CHANGED THE PERSONNEL WHO IS DOING THE REFILLS OUT OF THE OFFICE¿. THE PATIENT HAD BEEN ASKING FOR THE IMPLANTING HCP TO CHECK THE PUMP, BUT THEY REPORTEDLY ¿SAY NO, NO, IT¿S OK¿. THE PUMP WAS REFILLED ON (B)(6) 2014. IT WAS NOTED THE PATIENT THOUGHT THAT SEEMS ¿PRETTY CLOSE TOGETHER¿, BUT THE PATIENT HADN¿T KEPT TRACK. THE NEW HCP¿S ASSISTANT DID THE REFILLS STARTING ON (B)(6) 2014. IT WAS ALSO REPORTED THE PATIENT FELT LIKE HE HAD NOTICED A CHANGE IN HIS THERAPY SINCE THE (B)(6), AFTER THE (B)(6) REFILL. THE PATIENT DIDN¿T KNOW IF THERE WAS A CHANGE IN THE DRUG. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT PROVIDED. IT WAS FURTHER REPORTED THE PATIENT WAS HAVING ¿TROUBLE WITH THE PAIN PUMP IN MY SIDE¿. IT WAS THEN REPORTED THE PATIENT¿S PCP (PRIMARY CARE PHYSICIAN) WONDERED IF THE PATIENT WAS BEING OVERMEDICATED. THE PATIENT THEN SPOKE WITH A NURSE AT THE MANAGING HCP¿S OFFICE WHO HAD DONE THE PAST TWO REFILLS AND ¿HE THOUGHT EVERYTHING IS OK¿. IT WAS NOTED THE PATIENT¿S PCP DIDN¿T WANT TO BE INVOLVED ANY FURTHER. IN TERMS OF SYMPTOMS, IN THE (B)(6) THE PATIENT STARTED HAVING CONSTIPATION REALLY BAD ¿ALMOST LIKE ROCKS¿ AS WELL AS FLUSHNESS. HE WOULD TURN BEET RED, BUT DIDN¿T HAVE A TEMPERATURE. THE PATIENT HADN¿T EVER HAD THIS BEFORE AND UP UNTIL THEN IT HAD BEEN WORKING¿PRETTY GOOD¿. IT WAS NOTED THERE HAD BEEN SOME DOSE/CONCENTRATION ADJUSTMENTS. THE PATIENT BELIEVED THERE WERE TWO DRUGS IN THE PUMP, BUT WASN¿T REALLY SURE WHAT THEY WERE. THE PATIENT WAS UNSURE WHAT TO DO NEXT AND DIDN¿T WANT TO LOSE THEIR PCP. THE PATIENT WASN¿T AWARE OF ANY VOLUME DISCREPANCIES. THE PUMP WAS GOING TO BE CHECKED ON (B)(6) 2014, BUT NOT REFILLED. THE PATIENT THOUGHT THEY HAD BEGUN TO THINK SOMETHING MIGHT BE WRONG ¿SHORTLY AFTER¿ THE (B)(6) 2014 REFILL. IT WAS REPORTED THE PATIENT WOULD BE GREATLY RELIEVED TO FIND OUT THE PUMP IS WORKING CORRECTLY. IT WAS LATER REPORTED THAT THE PUMP DELIVERED HYDROMORPHONE AND BUPIVACAINE. IN TERMS OF WHAT WAS THE CAUSE OF THE SYMPTOMS, IT WAS UNKNOWN. THERE HADN¿T BEEN A CHANGE TO THE PATIENT¿S INFUSION RATE SINCE (B)(6) 2014. THE HEALTH CARE PROVIDER (HCP) INDICATED THERE WAS NO OVER MEDICATION. IT WAS UNKNOWN, HOWEVER, IF THE ISSUE HAD BEEN RESOLVED. IN TERMS OF PATIENT OUTCOME, IT WAS NOTED THE PATIENT WAS AN ANXIOUS INDIVIDUAL WITH CONSTIPATION. IT WAS THEN NOTED THERE AS AN APPOINTMENT SCHEDULED TO REDUCE THE INFUSION RATE. THE PATIENT WAS TOLD BY ANOTHER HCP THAT HIS INTRATHECAL OPIOID WAS CAUSING HIS CONSTIPATION. PER SESSION DATA REPORTS FROM WHEN THE PUMP WAS INTERROGATED ON (B)(6) 2014, NOTHING ABNORMAL WAS NOTED. PER A NOTE FROM A PUMP REFILL ON (B)(6) 2014, IT WAS NOTED THE PATIENT WAS MUCH LESS DYSPNEIC THAN HE WAS AT THE LAST VISIT. THE PATIENT WAS USING SUPPLEMENTAL OXYGEN BY WAY OF NASAL PRONGS. IN TERMS OF THE PATIENT¿S VITAL SIGNS, HIS HEART RATE WAS 72 AND ¿IRREGULARLY IRREGULAR¿. IT WAS REPORTED THE PATIENT CONTINUED TO STRUGGLE WITH SEVERE LOW BACK AND LOWER EXTREMITY PAIN WHICH HE DESCRIBED AS A 6 OR 7 ON A STANDARD SCALE OF 0 TO 10. THE PATIENT HAD BEEN DECREASING HIS USE OF ACETAMINOPHEN AND WAS MANAGING PRETTY WELL. IT WAS LATER REPORTED THE PATIENT DIDN¿T HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE FROM THEIR HEALTH CARE PROVIDER (HCP) OR DEVICE MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED, IT WAS NOTED IN TERMS OF AN APPOINTMENT ¿ONLY WITH AN ASSISTANT¿. IT WAS ALSO HOWEVER REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HCP OR DEVICE MANUFACTURER REPRESENTATIVE, NO APPOINTMENT HAD BEEN SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509232 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Other