BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2740048 · Received September 11, 2012

    Report

    Report Number
    3004209178-2012-07994
    Event Type
    Injury
    Date Received
    September 11, 2012
    Report Date
    August 21, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE CATHETER, PRODUCT ID 8575, LOT# N152945, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING HALLUCINATIONS. THE PATIENT STATED THAT SOMETIMES WHILE READING A BOOK, "SHE CLOSES HER EYES AND THEN SHE COMES UP WITH A CONCLUSION TO THE END OF THE BOOK". THE PATIENT "FEELS LIKE SHE FINISHES IT WITHOUT ACTUALLY READING IT". THE PATIENT WAS WORKING WITH A PSYCHIATRIST REGARDING THE HALLUCINATIONS. THE MEDICATIONS IN THE PUMP WERE CLONIDINE, BUPIVACAINE, AND DILAUDID. THE PATIENT LATER REPORTED THAT THEY CONTINUED TO HAVE DEVICE/THERAPY CONCERNS. IT WAS LATER REPORTED THAT THE PATIENT SAW THEIR HCP FOR A REFILL ON (B)(6) 2012, AND HCP STATED THERE WAS 'NO MENTION OF HALLUCINATIONS' TO THE HCP. THE HCP WAS UNSURE OF WHY THE PATIENT WAS HAVING HALLUCINATIONS. HCP INDICATED THAT THE PATIENT WAS ON 'HIGH DOSES OF MEDICATIONS, BOTH IN INFUSION SYSTEM AND ORAL MEDS', AND THAT THE OVERALL MEDICATION DOSES ARE 'TOO HIGH', HOWEVER THEY ARE TRYING TO BRING HER MEDICATION LEVELS DOWN. THE HCP HAD LOWERED INFUSION AND ORAL MEDICATION DOSES AND CONCENTRATIONS. THE PUMP DOSE WAS 'RECENTLY' REDUCED BY 10% (OF THE HYDROMORPHONE). AT THE LAST REFILL, DAILY DOSE OF HYDROMORPHONE WAS LOWERED TO 23.5 MG/DAY. THE PATIENT ALSO WAS TAKING ORAL OXYCODONE. THE MEDICATIONS IN THE PUMP WERE CLONIDINE, BUPIVACAINE, AND DILAUDID. THE PATIENT LATER REPORTED THAT THEY CONTINUED TO HAVE DEVICE/THERAPY CONCERNS; HOWEVER THEY WERE WORKING WITH THEIR HCP. ADDITIONAL INFORMATION HAD BEEN REQUESTED, HOWEVER WAS NOT YET RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other