BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3140496 · Received May 31, 2013

    Report

    Report Number
    3007566237-2013-01814
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFLAMMATORY MASS AT THE CATHETER TIP. THE PATIENT HAD AN MRI RECENTLY WHICH SHOWED AN ABNORMAL TISSUE AT THE CATHETER TIP. THERE WERE NO PUMP VOLUME DISCREPANCY REPORTED. THE PATIENT¿S ¿NORMAL¿ PAIN WAS NOT COMPLETELY UNDER CONTROL. THE PUMP WAS NEARING END OF LIFE AT A NORMAL PACE. THE PATIENT¿S CATHETER WAS REPLACED WITH AN ASCENDA CATHETER DURING THE PATIENT¿S PUMP REPLACEMENT TIME FOR NORMAL BATTERY DEPLETION. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY, NO ADVERSE EVENT. THE PUMP WAS USED TO DELIVER DILAUDID AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS WALKING IN 2010; SHE WENT FROM WALKING TO USING A CANE TO USING A WALKER. ONE MORNING SHE GOT UP AND COULDN'T MOVE HER LEGS; SHE COULD STAND UP, BUT COULDN'T WALK. IN (B)(6) OF 2011, AN MRI WAS DONE, BUT THE PATIENT NEVER HEARD THE RESULTS OF THE MRI. THE PATIENT THEN MOVED AND STARTED TO SEE A NEW PHYSICIAN IN (B)(6) OF 2012. WHEN HE DID AN EXAMINATION, THE PATIENT HAD NO RESPONSE FROM REFLEXES. HE ORDERED ANOTHER MRI. THEY FOUND A HUGE MASS/GRANULOMA, AS WELL AS 5 HERNIATED DISCS. THE DOCTOR TOLD THE PATIENT THAT SHE HAD 3X THE AMOUNT OF MEDICATION IN THE PUMP THAN WHAT TECHNICALLY ALLOWED. THE PATIENT WAS SLOWLY WEANED FROM THE MEDICATIONS IN THE PUMP. THE DOCTOR "SURGICALLY CLEANED EVERYTHING UP". THE PATIENT STATED THAT SHE "BASICALLY HAD A CHOKED OFF CATHETER BECAUSE OF THE GRANULOMA AND WAS IN CONSTANT PAIN". "WHEN THEY WOULD WITHDRAW THE OLD MEDICINE, WOULD DRAW OUT 6 UNITS, SHOULD HAVE BEEN 2-3 UNITS; 6 WAS TOO MUCH." FOLLOWING THE PUMP AND CATHETER REPLACEMENT PROCEDURE, THE PATIENT HAD SALINE IN THE PUMP. MEDICATION WAS PUT IN THE NEW PUMP IN LATE (B)(6) OF 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240857 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Other| R