BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4903590 · Received July 9, 2015

    Report

    Report Number
    3004209178-2015-13100
    Event Type
    Injury
    Date Received
    July 9, 2015
    Report Date
    June 16, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8835, SERIAL# (B)(4) PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8780, SERIAL# (B)(4) IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT¿S PAIN WAS NOT RELIEVED BY INCREASES IN MEDICATION. PATIENT WAS EXAMINED ON (B)(6) 2013 AND FOUND TO HAVE UNRELIEVED PAIN SCORED AS 8/10. DRUG DELIVERED VIA THE DEVICE WAS HYDROMORPHONE. MEDICATION ADJUSTMENTS WERE DONE AS FOLLOWING: 10% INCREASE IN RATE ON (B)(6) 2013; 20% INCREASE ON (B)(6) 2013 ; 20% INCREASE ON (B)(6) 2013 AND 20% INCREASE ON (B)(6) 2013. DRUG WAS CHANGED TO MORPHINE ON (B)(6) 2013. CAUSE WAS ATTRIBUTED TO HYDROMORPHONE DRUG ACTION. THE PUMP WAS CHECKED UNDER FLUOROSCOPY AND INDICATED TO BE A NORMAL PUMP CHECK ON (B)(6) 2013. PATIENT WAS THEN EXAMINED ON (B)(6) 2014 AND NOTED TO HAVE IMPROVED PAIN WITH NO SIDE EFFECTS. PATIENT OUTCOME WAS STATED AS RESOLVED WITHOUT SEQUELA. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED LOSS OF PAIN RELIEF AFTER CHANGE TO HYDROMORPHONE AND THE PAIN DID NOT IMPROVE WITH INCREASES IN RATE. ADDITIONAL INFORMATION RECEIVED REPORTED THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2015. THE DEVICE WAS DISPOSED OF ACCORDING TO BIOHAZARD INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445596 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention