BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5413037 · Received February 5, 2016

    Report

    Report Number
    3004209178-2016-01606
    Event Type
    Injury
    Date Received
    February 5, 2016
    Report Date
    January 14, 2016
    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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATING THAT A "MRW" PUMP WAS IMPLANTED ON (B)(6) 2016. THEN ON (B)(6) 2016, THE COMPANY REPRESENTATIVE INDICATED THAT THE PUMP WOULD NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL MORPHINE (5.4 MG/ML, 6.6102 MG/DAY) AND BUPIVACAINE (7.3 MG/ML, 8.936 MG/DAY) VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE WAS NOT NOTED. THE EVENT DATE, THE DRUG LOT NUMBERS, THE CONCOMITANT MEDICATION LIST, AND THE PATIENT AGE/WEIGHT/MEDICAL HISTORY WERE LISTED AS UNABLE TO OBTAIN. IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION OCCURRED APPROXIMATELY 3.5 YEARS AFTER THE IMPLANT. THE ISSUE WAS IDENTIFIED BY THE ELECTIVE REPLACEMENT INDICATOR (ERI) ALARM. THE ALARM SOUNDED AND THE PATIENT WENT TO THE DOCTOR. THE PUMP WAS INTERROGATED AND GAVE THE ERI ALARM. THE SENT LOGS INDICATED THAT ERI OCCURRED ON (B)(6) 2016. THE PUMP WAS TO BE REPLACED "THE NEXT WEEK" (THE WEEK AFTER (B)(6) 2016). THE ISSUE WAS NOT RESOLVED AND THE HCP HAD NO FURTHER INFORMATION. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS "ALIVE - NO INJURY". ADDITIONAL DETAILS ABOUT WHAT HAPPENED TO THE PATIENT, RELEVANT TO THIS EVENT, WERE NOT SPECIFIED. ON (B)(6) 2016 THE COMPANY REPRESENTATIVE REPORTED THAT HE DID NOT KNOW FOR SURE IF THE PATIENT HEARD THE ALARM. HE ALSO NOTED THAT THE PATIENT DID NOT HAVE A LOWER DRUG CONCENTRATIONS AND THUS HIGH DAILY DOSES, IN THE PAST. ADDITIONAL INFORMATION WAS REQUESTED REGARDING FURTHER ACTIONS INTERVENTIONS TAKEN. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72391 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention