BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3610989 · Received February 6, 2014

    Report

    Report Number
    3007566237-2014-00391
    Event Type
    Injury
    Date Received
    February 6, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    PLEASE SEE H.10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4). (SENSORY LOSS/RETURNED TO NORMAL SENSATION). (B)(4). SINCE THE PUMP SERIAL # IS UNKNOWN, FOLLOWING ARE THE RECALL #S IDENTIFIED FOR INFLAMMATORY MASS : Z-1142-2008 Z-1143-2008 Z-1144-2008 Z-1145-2008 Z-1146-2008 Z-1147-2008 Z-1148-2008 Z-1149-2008 Z-1150-2008 Z-1151-2008 Z-1152-2008 Z-1153-2008 Z-1154-2008.

    Description of Event or Problem · 1

    DALM, B. D., BRENNAN, T. J., ELAHI, F., HOWARD, M. A., 3RD, REDDY CG. SUCCESSFUL CONSERVATIVE MANAGEMENT OF AN INTRATHECAL CATHETER-ASSOCIATED INFLAMMATORY MASS. THE SPINE JOURNAL : OFFICIAL JOURNAL OF THE NORTH AMERICAN SPINE SOCIETY. 2013;13(11):1708-1709. SUMMARY: ARTICLE DESCRIBES A (B)(6) WOMAN WHO EXPERIENCED GRADUAL MOTOR AND SENSORY LOSS OVER SEVERAL WEEKS. CT IMAGES DEMONSTRATED A CATHETER TIP INFLAMMATORY MASS. SURGERY WAS POST-PONED DUE TO BRADYCARDIA. DOWNWARD TITRATION OF IT MEDICATIONS IMPROVED HER PHYSICAL EXAMINATION. MRI SHOWED DECREASED SIZE OF THORACIC MASS. REPORTED EVENT: A (B)(6) WOMAN WITH MULTIPLE PRIOR SPINAL SURGERIES AND INTRATHECAL (IT) PAIN PUMP PRESENTED WITH GRADUALLY PROGRESSIVE MOTOR AND SENSORY LOSS OVER SEVERAL WEEKS. ON EXAMINATION, SHE HAD AN INCOMPLETE T8 PARTIAL SENSORY LEVEL AND MEDICAL RESEARCH COUNCIL 1-2/5 MOTOR STRENGTH IN HER LOWER EXTREMITIES. THE PATIENT ALSO DEVELOPED HYPOKINESIA. COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING DEMONSTRATED A CATHETER TIP INFLAMMATORY MASS (CIM) AT THE T9¿T10 LEVEL. HER IT MEDICATIONS WERE AS FOLLOWS: MORPHINE 60 MG/ML CONCENTRATION AT 137.8 MG/DAY; CLONIDINE 400 MCG/ML AT 918.92 MCG/DAY; SUFENTANIL 250 MCG/ML CONCENTRATION AT 574.32 MCG/DAY; AND BACLOFEN 200 MCG/ML CONCENTRATION AT 459.46 MCG/DAY. IN ADDITION, SHE WAS ON FENTANYL TRANSDERMAL 75 MCG/72 HOURS AND ORAL PERCOCET (DOSE UNKNOWN). THE PATIENT WAS ADMITTED, STARTED ON INTRAVENOUS MORPHINE PATIENT CONTROLLED ANALGESIA, AND PLANNED FOR EMERGENT SURGERY, BUT THIS WAS POSTPONED DUE TO SYMPTOMATIC BRADYCARDIA. WHILE UNDERGOING CARDIAC EVALUATION, SHE WAS NOTED TO REGAIN SOME STRENGTH IN HER LOWER EXTREMITIES, WITH IMPROVEMENT OF ONE MEDICAL RESEARCH COUNCIL GRADE IN EACH LOWER LIMB. GIVEN THIS IMPROVEMENT, AND THE CONCERN FOR SEVERE OPIATE WITHDRAWAL, GIVEN HER HIGH DOSES OF IT NARCOTICS, THE DECISION WAS MADE TO POSTPONE SURGERY. THE PAIN SERVICE WAS CONSULTED, WITH GRADUAL DOWN TITRATION OF HER IT RATE AND DILUTION WITH NORMAL SALINE, WITH EVENTUAL TRANSITION TO NORMAL SALINE OVER THE COURSE OF 17 DAYS. HER PHYSICAL EXAMINATION SLOWLY IMPROVED THROUGHOUT THE HOSPITAL STAY OF 5 WEEKS, AND BY THE TIME OF DISCHARGE, THE PATIENT WAS AMBULATORY WITH 4 TO 5 STRENGTH IN HER LOWER EXTREMITIES, WITH RECOVERY OF NORMAL SENSATION. REPEAT MAGNETIC RESONANCE IMAGING SHOWED DECREASED SIZE OF THE THORACIC MASS WITH DECREASED SPINAL CORD COMPRESSION (FIGURE, C AND D). SHE WAS PLANNED FOR ELECTIVE REMOVAL OF THE IT PUMP BUT WAS LOST TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77167 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R