BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4802408 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-09839
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    May 5, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODES WERE UPDATED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8575, LOT # N271115, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, LOT # J0058228R, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PUMP PROBLEM RELATED TO AN ALARM. THE PUMP HAD BEEN ALARMING FOR TWO MONTHS (TELEMETRY HAS NOT BEEN PERFORMED) AND THE PATIENT NEEDED IT TURNED OFF. THE PATIENT STATED THAT THE PUMP HAS BEEN EMPTY ¿FOR MONTHS¿ BECAUSE THE PAIN CENTER DID NOT ORDER MEDICATION FOR REFILL IN OCTOBER. THE PATIENT STATED HE DID NOT WANT THE PUMP ANYMORE AND JUST WANTED IT TURNED OFF. THE PUMP WAS USED TO INFUSE MORPHINE (UNKNOWN). NO INTERVENTION WAS REPORTED FOR THIS EVENT. FOLLOW UP WAS CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT'S PHYSICIAN REPORTED THAT THE PUMP HAD BEEN EMPTY SINCE (B)(6) 2015 PER THE EVENT LOGS. IT WAS INDICATED THAT THE PATIENT MISSED A PUMP REFILL. THERE WERE NO OTHER ABNORMAL EVENTS IN THE LOGS BUT THE PHYSICIAN STATED THAT HE WAS TOLD THE PUMP HAD BEEN ALARMING FOR A YEAR. THE LAST REFILL HAD BEEN ON (B)(6) 2014. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED "HORRIBLE WITHDRAWAL. " THE PHYSICIAN WAS TO REFILL THE PUMP WITH SALINE ON (B)(6) 2015 AND PROGRAM THE PUMP TO MINIMUM RATE MODE UNTIL IT COULD BE EXPLANTED. THE PATIENT WANTED THE PUMP EXPLANTED. THE PHYSICIAN STATED THAT THE PREVIOUS MANAGING PHYSICIAN HAD AN UNUSUAL COCKTAIL OF INTRATHECAL DRUGS IN THE PUMP. THE PUMP DELIVERED INTRATHECAL BACLOFEN "5CG/ML" AT A RATE OF 0.55MCG/DAY, MORPHINE 50MG/ML AT A RATE OF 5.45MG/DAY, MARCAINE 25MCG/ML AT A RATE OF 2.72MCG/DAY, AND ANOTHER UNKNOWN MEDICATION WITH A CONCENTRATION OF 7.5MG/ML AT A RATE OF 0.81MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347369 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other| R