BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2140960 · Received June 21, 2011

    Report

    Report Number
    3007566237-2011-04633
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    August 1, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PARESTHESIAS; EXTRAMEDULLARY INTRADURAL ROUND MASS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: DE ANDRES J, TATAY VIVO J, PALMISANI S, VILLANUEVA PEREZ VL, MINGUEZ A. INTRATHECALGRANULOMA FORMATION IN A PT RECEIVING LONG-TERM SPINAL INFUSION OF TRAMADOL. PAIN MEDICINE. 2010;11(7):1059-1062. SUMMARY: THE AUTHORS REPORT A CASE OF A SPINAL GRANULOMA FOUND IN A PT RECEIVING LONG-TERM INTRATHECAL INFUSION OF TRAMADOL FOR NONMALIGNANT CHRONIC PAIN. REPORTABLE EVENT: THE AUTHORS REPORT THAT A (B)(6), FEMALE, WITH MORBID OBESITY, HYPERTENSION, AND DYSLIPIDEMIA ON TREATMENT AND A HISTORY OF STROKE IN 1991, WITHOUT RESIDUAL NEUROLOGICAL DEFICITS. AN INFUSION SYSTEM WAS IMPLANTED AND INTRATHECAL TRAMADOL WAS STARTED WHICH WAS MAINTAINED FOR A PERIOD OF 30 MONTHS WITH NO PROBLEMS. HOWEVER, FROM THAT TIME ON, A PROGRESSIVE INCREASE OF THE DAILY TRAMADOL DOSE WAS NEEDED TO ACHIEVE THE SAME LEVEL OF INITIAL PAIN CONTROL. IN (B)(6) 2002, THE PT REPORTED A FEELING OF NUMBNESS ON THE OUTER SIDE OF THE LEFT LOWER LIMB, WHICH BECAME MORE SEVERE AT SUBSEQUENT FOLLOW-UPS. EVEN THOUGH THE DAILY TRAMADOL DOSE WAS INCREASED, NO IMPROVEMENT WAS ACHIEVED. TWO WEEKS LATER, THE PT EXPERIENCED A SUDDEN EXACERBATION OF HER SYMPTOMS WITH SEVERE PARESTHESIAS IN HER LOWER LIMBS AND A SIGNIFICANT REDUCTION OF HER WALKING ABILITY. SHE UNDERWENT A MAGNETIC RESONANCE SCAN SHOWING DEGENERATIVE BONE CHANGES AT LUMBAR LEVELS L3-L4 WITH GLOBAL DISK PROTRUSION OF L4-L5, A SIGNIFICANT REDUCTION IN THE LEFT RADICULAR FORAMEN AT L5-S1, AND AN EXTRAMEDULLARY, INTRADURAL ROUND MASS AT THE LEVEL OF THE VERTEBRAL BODY OF T9, LOCATED ON THE LEFT SIDE OF THE SPINAL CANAL AND CAUSING A STENOSIS OF THE SPINAL CANAL. THE PT UNDERWENT A DORSAL LAMINECTOMY OF T9 AND T10 WITH EXPOSURE AND SUBSEQUENT COMPLETE REMOVAL OF A MASS LOCALIZED AROUND THE CATHETER, WHICH WAS ALSO REMOVED AND REPLACED. A FEW DAYS INTO THE POSTOPERATIVE PERIOD, THE PT SHOWED A SIGNIFICANT IMPROVEMENT OF HER MOTOR DEFICIT AND PARTIAL IMPROVEMENT OF HER SENSORY DEFICIT. SPINAL ADMINISTRATION OF TRAMADOL WAS RESUMED. THE PT CURRENTLY HAS ADEQUATE PAIN CONTROL AND NO FURTHER NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL CATHETER, LOT # UNKNOWN