BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200795 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02172
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007 THIS PATIENT REPORTED EXCESSIVE AMOUNT OF PAIN IN HIS BACK AND DOWN HIS LEGS, MOSTLY IN THE RIGHT LEG, AND ¿ALMOST A NEUROPATHIC PAIN SYNDROME.¿ THE PATIENT WAS SENT FOR A DRUG SCREENING, HAD HIS PUMP REFILLED AND WAS TO HAVE FURTHER REVIEW OF HIS CATHETER. THE PATIENT WAS SEEN ON (B)(6) 2007 FOR A PUMP REFILL AND PAIN WAS REPORTED. THE PLAN WAS TO MANAGE HIS PAIN UNDER CONTROL THE BEST THE PHYSICIAN COULD. ON (B)(6) 2007 IT WAS NOTED THAT THE POSITION OF THE PATIENT¿S PUMP WAS ¿BAD.¿ THE PATIENT CONTINUED TO HAVE PAIN IN THE ¿LS¿ SPINE WHICH RADIATED DOWN INTO THE RIGHT FOOD AND HE CONTINUED TO HAVE ¿MULTIPLE ISSUES.¿ THE PATIENT WAS HYPERREFLEXIC IN THE PATELLA AND ACHILLES. THE PATIENT WAS PLACED ON MOTRIN AND HAD FURTHER LAB WORK UPS; BUN, CREATINE. LFTS AND HEPATITIS C. THE PATIENT WAS TO BE SET UP FOR A PUMP AND CATHETER REVISION. ON (B)(6) 2007 THE PUMP WAS REFILLED. THE PATIENT REPORTEDLY HAD NOT SHOWN UP TWICE FOR SURGERY AND HIS PAIN CONTINUED IN HIS LEGS. THE PUMP WAS IMPLANTED DUE TO PAIN AND THE ORAL MEDICATION WAS ¿SCREWING UP¿ HIS STOMACH. ON (B)(6) 2007 THE PATIENT¿S PUMP WAS REFILLED, HE HAD ONGOING PAIN AND DIMINISHED MOTOR TONE IN THE ANTERIOR MOTOR GROUPS. IT WAS REPORTED AT THAT TIME THAT THE PATIENT¿S CATHETER AND PUMP WERE TO BE REPLACED. ON (B)(6) 2007 THE PUMP WAS INCREASED AND ZOFRAN WAS PRESCRIBED. THE PATIENT REPORTED TO BE IN EXCESSIVE AMOUNT OF PAIN IN THE LS SPINE, ABDOMEN AND BACK AND WAS ¿IN A LITTLE BIT OF WITHDRAWAL.¿ PROGRAMMING WAS ALSO DONE ON THIS DATE AND THE PATIENT DID ¿VERY WELL.¿ THE PATIENT WAS SEEN AGAIN ON (B)(6) 2007 FOR A REFILL AND HE HAD PAIN IN THE POSTERIOR OF HIS LEFT LEG. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2008 AND HIS PUMP WAS ¿INCREASED TO 8¿ AS THE PATIENT¿S PAIN CONTINUED. THE PATIENT WAS SEEN AGAIN FOR A REFILL ON (B)(6) 2008. THIS DEVICE SYSTEM DELIVERED MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303137 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention