BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5775107 · Received July 7, 2016

    Report

    Report Number
    3004209178-2016-13667
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    June 10, 2016
    Report Date
    October 17, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED CORROSION AND WEAR ON THE INTERNAL GEARS INSIDE OF THE MOTOR, INDICATIVE OF A STALL DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A MOTOR STALL WAS SEEN AT INITIAL INTERROGATION. THE REPORTER WAS CALLED TO CHECK THE PATIENT'S PUMP THAT HAD A MOTOR STALL AND HAD BEEN STOPPED. THE HEALTHCARE PROVIDER PLANNED TO REPLACE THE PUMP ON (B)(6) 2016. HOWEVER, PER THE REPORTER THE FACILITY WOULD NOT RELEASE THE PUMP FOR ANALYSIS AS THEY HAD THEIR OWN PROCESS TO EVALUATE THE PUMP FIRST. THE REPORTER ALSO COULD NOT CHECK THE LOGS AND REVIEWED SCREENS THAT SOUNDED LIKE THE PUMP WAS OFF. THE REPORTER STATED THAT THE PUMP WAS NOT OFF BUT SIMPLY STOPPED. IT WAS ALSO CONFIRMED THAT THE CODE TO PERMANENTLY TO TURN THE PUMP OFF WAS PROVIDED ON (B)(6) 2016.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) AND CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL BUPIVACAINE 3.5 MG/ML AT 0.7867 MG/DAY AND MORPHINE 20 MG/ML AT 4.496 MG/DAY. THE INDICATIONS FOR USE WERE NON-MALIGNANT PAIN AND PERIPHERAL CAUSALGIA. IT WAS REPORTED THAT THE PATIENT WAS LIGHT HEADED AND NOT FEELING WELL. THEIR BLOOD PRESSURE WAS GOOD (156/83), AND THEIR HEART RATE WAS 83. A MOTOR STALL WAS SEEN AT INITIAL INTERROGATION. THE PUMP STALLED ON (B)(6) 2016. THE PATIENT HAD NOT RECENTLY HAD AN MRI. THE HCP WAS UNSURE IF THE PUMP WOULD BE REPLACED. THE HCP WANTED TO PERMANENTLY DISABLE THE PUMP. IT WAS LATER REPORTED THAT THE PATIENT ASKED FOR A HCP TO REMOVE AND REPLACE THE PUMP THAT HAD ¿STOPPED TOO EARLY¿ BUT THE PATIENT DID NOT CURRENTLY HAVE A HCP (FROM (B)(6) 2016). THE LISTING IN HIS STATE WOULD NOT TAKE HIM. THE PATIENT WAS TO SEE ONE HCP, BUT THAT HCP WAS NOT AVAILABLE UNTIL (B)(6) 2016. THE PATIENT REPORTED NEEDING TO GET HIS PUMP REPLACED AS SOON AS POSSIBLE DUE TO INCREASED BACK PAIN AND HYPERTENSION AS A RESULT OF HIS INCREASED PAIN. THE PATIENT HAD BLOOD PRESSURES OF 191/169, 201/179, 145/76 (RESTING). THE PATIENT¿S ORAL PERCOCET HE WAS TAKING WAS ELEVATING HIS LIVER.

    Description of Event or Problem · 1

    NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Description of Event or Problem · 1

    THE PUMP WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429004 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention