BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2853360 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-11012
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8575, LOT# N180850, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT WHEN THE PUMP WAS IMPLANTED HE WAS IN THE HOSPITAL FOR SIX DAYS WITH A SPINAL HEADACHE FROM THE NEEDLE BEING PUT INTO HIS SPINE IMPROPERLY. THE PUMP WAS REMOVED 2 ½ YEARS AGO DUE TO HIS IDIOPATHIC NEUROPATHY PAIN. THE PATIENT WAS GETTING SPINAL HEAD ACHES AND WAS ON A HIGH DOSE OF MEDICATION THEREFORE HE COULD NOT FUNCTION. WHEN THE DOSE WAS DECREASED, THE PATIENT DID NOT EXPERIENCE PAIN RELIEF. THE PAIN WAS IN HIS FEET. PATIENT STATED A PERSONAL THERAPY MANAGER WAS NOT AVAILABLE FOR THE PUMP. WHATEVER INCREASE IN MEDICATION HE GOT, HIS PAIN WOULD BE TOO MUCH. PATIENT LOST HIS JOB AND INSURANCE AS RESULT OF NOT HAVING PAIN CONTROL, THUS HIS PUMP WAS REMOVED. PATIENT STATED IT "ABSOLUTELY DESTROYED HIS LIFE BECAUSE HE DIDN'T KNOW WHO HE WAS ANYMORE." IN ORDER TO CONTROL THE PAIN THAT HE WAS SUFFERING FROM HE WOULD HAVE IT ADJUSTED TO THE POINT HE "WASN'T THERE ANYMORE." THE PATIENT TRIED TO VARY WITH ORAL MEDICATIONS AND IT WAS JUST TOO DIFFICULT. HE WAS HURTING HIMSELF, WASN'T THINKING PROPERLY, LOST HIS JOB AND HAD IT TAKEN OUT BECAUSE IT WAS A NIGHTMARE. THEY PUT THE DILAUDID IN AND IT WORKED FINE AND IT WORKED REALLY WELL BUT THE PATIENT COULDN'T FUNCTION PROPERLY ANYMORE, SO HE HAD IT TURNED DOWN AND THEN HE COULDN'T WALK AND COULDN'T SLEEP BECAUSE OF THE PAIN. THERE WAS NO "HAPPY MEDIUM" WITH THE PUMP. PATIENT WAS CONSIDERING GETTING A PUMP PUT IN NOW THAT THERE WAS A PERSONAL THERAPY MANAGER AVAILABLE SO HE COULD HAVE SOME CONTROL OVER THE DRUG. PATIENT STATED HE WASN'T TOLD ABOUT THE PERSONAL THERAPY MANAGER PREVIOUSLY WHICH WOULD HAVE HELPED HIM. THE PATIENT WAS FOLLOWING UP WITH A HCP AND WAS SEEKING A SURGEON TO IMPLANT THE PUMP. THE PUMP WAS DELIVERING DILAUDID AND MORPHINE.

    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 Required Intervention