BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4961982 · Received August 3, 2015

    Report

    Report Number
    3004209178-2015-14549
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    May 16, 2013
    Report Date
    June 4, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835; PRODUCT TYPE PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER IN REGARD TO A PATIENT RECEIVING DILAUDID 3.0 MG/ML AT 1.5018 MG/DAY VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE PATIENT HAD TO GO TO (B)(6) TO HAVE THE CATHETER REPLACED AS THERE ARE NO PHYSICIANS IN (B)(6) THAT WILL FOLLOW HER. THE PATIENT MENTIONED THAT WHEN SHE HAD DIAGNOSTIC TESTING PERFORMED THAT WAS PAINFUL. THE CATHETER HAD BEEN REPORTEDLY FAULTY AND LEAKING POSSIBLY SINCE DAY 1. AFTER THE CATHETER WAS REPLACED THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CHANGE IN THERAPY EFFECT. THE PATIENT EXPERIENCED SEVERE PAIN NEAR HER LEFT KIDNEY AND A GRADUAL ONSET LOW BACK PAIN 3 DAYS PRIOR TO REPORT. THE PERSONAL THERAPY MANAGER (PTM) BOLUSES WERE NOT TOUCHING THE PATIENT PAIN WHICH BEGAN ON 2015 (B)(6). THE PATIENT TRIED AGAIN WITH A BOLUS THE DAY PRIOR TO REPORT AND THE PTM WAS NOT HELPING WITH THE PAIN. THE PATIENT EXPERIENCED SUDDEN HEADACHES THE PRIOR NIGHT. IT WAS NOTED THAT THE PATIENT HAD NOT HAD A HEADACHE IN MANY YEARS, AND NEVER GETS HEADACHES. NO ALARMS WERE HEARD AND THERE WERE NO CODES ON THE SCREEN OF THE PTM. THE PUMP WAS USED TO INFUSE DILAUDID. FURTHER INFORMATION WAS REPORTED THAT THE PATIENT HAD A "BAD CATHETER." IT WAS NOTED THAT IT BEEN SLOWLY LEAKING SINCE IMPLANT, AND KEPT GETTING WORSE AND WORSE. A DYE STUDY WAS PERFORMED THAT CONFIRMED THE LEAK, AND THE CATHETER WAS REPLACED. A MANUFACTURE REPRESENTATIVE WAS PRESENT FOR THE DYE STUDY AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504906 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention