BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3873285 · Received June 13, 2014

    Report

    Report Number
    3007566237-2014-01653
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    GÜZELKÜÇÜK, Ü., DUMAN, I., YILMAZ, B., TAN, A. K. [INTRATHECAL BACLOFEN THERAPY IN PATIENTS WITH TRAUMATIC SPINAL CORD INJURY.] TURKISH JOURNAL OF PHYSICAL MEDICINE AND REHABILITATION. 2013; 59: 281-285. DOI: 10.4274/TFTR.90582. SUMMARY: THE OBJECTIVE WAS TO EVALUATE THE DATA OF 15 TRAUMATIC SPINAL CORD INJURY (SCI) PATIENTS WHO WERE ADMINISTERED INTRATHECAL BACLOFEN (ITB) THERAPY. FIFTEEN PATIENTS WITH TRAUMATIC SCI WHO WERE ADMINISTERED ITB THERAPY WERE REVIEWED RETROSPECTIVELY. THE LEVEL OF SPASTICITY BEFORE AND AFTER ITB ADMINISTRATION, TIME INTERVAL BETWEEN SCI AND ITB ADMINISTRATION, FOLLOW-UP PERIOD AFTER ITB ADMINISTRATION, THE FIRST EFFECTIVE DOSE OF BACLOFEN PROVIDING REDUCTION OF SPASTICITY AFTER ITB ADMINISTRATION, THE FINAL ADMINISTERED DOSE OF BACLOFEN AND THE ITB COMPLICATIONS DEVELOPED DURING FOLLOW-UP PERIOD AFTER ITB ADMINISTRATION. EIGHT (53%) PATIENTS HAD TETRAPLEGIA AND SEVEN (47%) PATIENTS HAD PARAPLEGIA. THE AVERAGE FOLLOW-UP PERIOD AFTER ITB WAS 57.43±36.89 MONTHS. ACCORDING TO THE MODIFIED ASHWORTH SCALE (MAS), AVERAGE LEVELS OF SPASTICITY WERE 3.47±0.51 BEFORE ITB AND 1.50±0.51 AFTER ITB, AND THE DIFFERENCE BETWEEN THEM WAS STATISTICALLY SIGNIFICANT (P=0.001). THE AVERAGE FIRST EFFECTIVE DOSE OF BACLOFEN WAS 174.33±92.25 ¿G/DAY; THE FINAL DOSE OF BACLOFEN WAS 240.42±125.19 ¿G/DAY. THE DIFFERENCE BETWEEN COMPLETE AND INCOMPLETE PATIENTS IN TERMS OF THE FIRST AND THE FINAL BACLOFEN DOSE WERE STATISTICALLY SIGNIFICANT (P=0.012; P=0.018, RESPECTIVELY). COMPLICATIONS WERE OBSERVED IN NINE (60%) PATIENTS. ALTHOUGH ITB THERAPY IS AN EFFECTIVE TREATMENT METHOD FOR SEVERE AND INTRACTABLE SPASTICITY IN PATIENTS WITH TRAUMATIC SCI, SOME MEDICAL AND PUMP SYSTEM COMPLICATIONS MAY DEVELOP. REPORTED EVENT: WHILE THE DOSE WAS 100 ¿G/DAY, THREE DAYS AFTER ITB ADMINISTRATION, A PATIENT DEVELOPED DELIRIUM WITH CONFUSION, EMOTIONAL LABILITY AND HALLUCINATIONS. DANTROLENE WAS STARTED ON THE PATIENT, WHOSE ITB THERAPY WAS TERMINATED AND THE PUMP WAS REMOVED, DUE TO OBSERVING SIMILAR SYMPTOMS WITH PO BACLOFEN AND TIZANIDINE. SEE LITERATURE ARTICLE ATTACHED IN MANUFACTURER REPORT #3007566237-2014-01649.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349312 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention