BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3853205 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10243
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 2, 2014
    Report Date
    February 2, 2021
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8590-1, LOT# N138129, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT DATE UPDATED. DEVICE CODE (B)(4) NO LONGER APPLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS TOLD TO MEET WITH A MANUFACTURER REPRESENTATIVE (REP) ON (B)(6) 2014 AND HE CONFIRMED THE PATIENT WAS NOT GETTING DRUG AND THAT THE PUMP HAD MALFUNCTIONED. THE PATIENT WAS HAVING THE PUMP DECREASED FOR THE PAST 2-3 YEARS BECAUSE SHE DID NOT HAVE INSURANCE AND WANTED TO SPACE OUT HER REFILLS BECAUSE SHE WAS PAYING CASH FOR THEM. THE PATIENT WENT THROUGH SEVERE WITHDRAWAL FOR THE ENTIRE MONTH OF (B)(6) 2014 AND WENT TO THE EMERGENCY ROOM (ER) THREE TIMES. IT WAS NOTED THE THREE TIMES IN THE ER SHE WAS TOLD SHE HAD A NEW STRAND OF THE FLU. THE PATIENT THEN WENT FOR A REFILL ON (B)(6) 2014 AND THE PUMP REPORT SHOWED SHE WAS GETTING "ZERO DRUG" AFTER A 5% INCREASE AND THE PATIENT WAS TOLD TO MEET WITH A REP ON (B)(6) 2014 AT WHICH TIME HE CONFIRMED THE PATIENT WAS NOT GETTING DRUG AND THAT THE PUMP HAD MALFUNCTIONED. THE PUMP WAS TURNED OFF AT THIS APPOINTMENT BECAUSE IT WAS NOT WORKING. THE PATIENT HAD THE PUMP REPLACED ON (B)(6) 2014. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CRITICAL ALARM CONFIRMED BY TELEMETRY. THE ALARM WAS OCCURRING WAS ¿RESET OCCURRED ¿ LOW BATTERY. PUMP IN SAFE STATE.¿ THE PATIENT HAD INCREASED PAIN ABOUT 2 WEEKS AGO. INITIALLY THAT WAS THE PATIENT¿S ONLY SYMPTOM BUT THEN THE PATIENT FELT WITHDRAWAL-TYPE SYMPTOMS. THE PATIENT CAME IN FOR A REFILL ON TUESDAY THE WEEK OF THE REPORT AND THE PUMP WAS IN MINIMUM RATE MODE, BUT IT HAD ¿APPARENTLY¿ JUST BEEN REPROGRAMMED AND UPDATED. THE EVENT LOGS ONLY WENT BACK TO MAY 10 AND CONSISTED MOSTLY OF RESET ¿ LOW BATTERY LOGS. THERE WAS A MOTOR STALL RECOVERY LOG, BUT NO MOTOR STALL LOG. IT WAS NOT THOUGHT THE PATIENT HAD AN MRI, BUT SHE DID HAVE A CT SCAN RECENTLY. THE HEALTH CARE PROVIDER WANTED TO PROGRAM THE PUMP OFF AND MANAGE THE PATIENT WITH ORAL MEDICATION INSTEAD. THE SYSTEM WAS BEING USED TO DELIVER COMPOUNDED MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 2017-NOV-28 FROM THE CONSUMER (PATIENT) REPORTED HER FIRST PUMP STOPPED 1 YEAR BEFORE IT WAS SUPPOSED TO IN (B)(6) 2013 ON. THE PATIENT STATED THAT SHE HAD THE PUMP FOR 6 YEARS WHEN SHE SHOULD HAVE HAD IT FOR 7 YEARS. THE PATIENT STATED A MANUFACTURER REPRESENTATIVE WAS THERE TO CHECK HER PUMP AND TOLD HER THE PUMP WAS NOT WORKING. THE PATIENT STATED THE REPRESENTATIVE TURNED THE PUMP OFF. THE PATIENT STATED THE REPRESENTATIVE TOLD HER THE BATTERY MAYBE DIED. THE PATIENT STATED THAT SHE JUST HAD THE PUMP FILLED THAT DAY, AND THEN, THEY HAD TO DRAIN THE PUMP. THE PATIENT STATED A WEEK BEFORE SHE SAW THE REPRESENTATIVE IN(B)(6) 2013, SHE WAS GOING THROUGH WITHDRAWALS FOR A MONTH. THE PATIENT STATED SHE WENT TO FOUR EMERGENCY ROOMS. THE PATIENT STATED THE EMERGENCY ROOM ALSO FOUND A GALLSTONE THAT THEY REMOVED. THE PATIENT STATED WHEN SHE WAS GOING THROUGH WITHDRAWAL, SHE WISHED SHE WAS DEAD. THE PATIENT STATED THEY DETERMINED SHE WAS NOT GETTING ANY MEDICATION FROM THE LOGS THEY PULLED FROM THE PUMP. IT WAS UNKNOWN IF THE CHANGE IN THERAPY/SYMPTOMS WAS CONSIDERED SUDDEN OR GRADUAL. THE PATIENT STATED AT THE EMERGENCY ROOM, THEY THOUGHT THE PATIENT HAD THE FLU INSTEAD OF WITHDRAWALS. WITH THE OLD MEDICATION (UNKNOWN BRAND OF MORPHINE), THE PATIENT STATED HER DOSE WAS 30 MG/DAY, AND THE CONCENTRATION WAS 50 MG/ML. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332068 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention