BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5001966 · Received August 13, 2015

    Report

    Report Number
    3004209178-2015-16010
    Event Type
    Injury
    Date Received
    August 13, 2015
    Report Date
    July 27, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-9, LOT# N213886, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009-, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2015, THE PATIENT EXPERIENCED INCREASED PAIN AFTER THE PHYSICIAN TURNED THE PUMP DOWN TO ONE THIRD OF HIS DOSE. THE PUMP WAS DELIVERING "MORPHINE 10% AND DILAUDID 25%". THE DOSE WAS AT 15.9 MG/DAY BUT THE PHYSICIAN HAD SCALED IT BACK; THE PATIENT DIDN'T KNOW THE CURRENT DOSE. IT WAS NOTED THAT THE PATIENT STARTED GETTING GOOD EFFECT FROM THE PUMP WHEN THE PHYSICIAN ADDED THE DILAUDID TO THE MORPHINE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON (B)(6) 2015 REGARDING A CONFIRMED GRANULOMA FOLLOWING AN MRI IN (B)(6) 2015. THE GRANULOMA WAS 15CM. THE PATIENT HAD LOST THE FEELING IN HIS LEGS. THE PATIENT WAS TO MEET WITH THE SURGEON ON (B)(6) 2015 AND WOULD LIKE A MANUFACTURER REPRESENTATIVE PRESENT. THE PATIENT WAS INSTRUCTED A MANUFACTURER REPRESENTATIVE WOULD HAVE TO BE INVITED BY THE DOCTOR. IT WAS NOTED THE PATIENT HAD A PAIN MANAGEMENT DOCTOR, BUT NO MANAGING PUMP DOCTOR. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN DRUG INFORMATION, CONCOMITANT DRUGS, ACTIONS/INTERVENTIONS, AND ANY OTHER PERTINENT INFORMATION. HISTORY: NON-MALIGNANT PAIN, DEGENERATIVE DISC DISEASE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534131 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Other