BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203562 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-04808
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    July 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2012 THE PATIENT WAS DRINKING BEER AND WITH HIS MEDICATIONS HAD A BAD REACTION. THE REACTION WAS REPORTED AS A MENTAL BREAKDOWN. IT WAS NOTED THAT THE PATIENT HAD ALSO WEANED HIMSELF OFF OF HIS ANTIDEPRESSANT MEDICATIONS. THE PATIENT¿S WIFE HAD THE PATIENT ADMITTED TO A MENTAL HOSPITAL WHERE THE PATIENT WAS ADMITTED FOR ABOUT TWO WEEKS. WHILE THE PATIENT WAS ADMITTED THE HOSPITAL CHANGED THE DRUGS THE PATIENT WAS PRESCRIBED. AFTER BEING RELEASED FROM THE MENTAL HOSPITAL ON (B)(6) 2012 THE PATIENT HAD AN APPOINTMENT WITH THE PHYSICIAN WHO MANAGED THE PUMP, AND FAILED THE DRUG TEST WHICH NOTED DIFFERENT MEDICATIONS THAN SHE HAD PRESCRIBED. AS A RESULT THE PATIENT WAS DISMISSED BY THE DOCTOR. IT WAS NOTED THAT THE PHYSICIAN WOULD NOT LISTEN TO THE EXPLANATION ABOUT THE MENTAL HOSPITAL. THE PATIENT RECEIVED A CERTIFIED LETTER ON THIS ABOUT A MONTH LATER. IT WAS ALSO REPORTED THAT THE PATIENT WAS ALWAYS IN PAIN, AND WAS NERVOUS ABOUT NOT HAVING A DOCTOR OR BEING ABLE TO GET THE PUMP FILLED. THE PATIENT WAS REFERRED TO THEIR PRIMARY CARE PROVIDER FOR ASSISTANCE IN FINDING ANOTHER PHYSICIAN TO FILL THE PUMP. APPROXIMATELY TWO MONTHS LATER THE PATIENT REPORTED INCREASED PAIN AND INABILITY TO SLEEP AFTER THE PAIN MANAGEMENT PHYSICIAN DECREASED THE DOSE OF THE PUMP MEDICATION A "COUPLE MONTHS AGO", AND THAT HE ¿COULDN¿T TAKE IT ANYMORE¿. THE PATIENT WAS HAVING DIFFICULTY FINDING A NEW PHYSICIAN TO FILL THE PUMP. THE PATIENT WAS ENCOURAGED TO CONTINUE WORKING CLOSELY WITH HIS PRIMARY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304106 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization