BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1002276 · Received February 22, 2008

    Report

    Report Number
    2182207-2008-00858
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    January 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: SAVEIKA ET AL. "CYPROHEPTADINE FOR PEDIATRIC INTRATHECAL BACLOFEN WITHDRAWAL: A CASE REPORT": AM J PHYS MED REHABIL 2007;86(12):994-997.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: SAVEIKA ET AL. "CYPROHEPTADINE FOR PEDIATRIC INTRATHECAL BACLOFEN WITHDRAWAL: A CASE REPORT." AM J PHYS MED REHABIL 2007; 86(12):994-997. THIS ARTICLE PRESENTS THE CASE OF A FEMALE WITH A HISTORY OF CEREBRAL PALSY AND SPASTIC TETRAPLEGIA SUCCESSFULLY TREATED WITH INTRATHECAL BACLOFEN (ITB) FOR 18 MONTHS. SHE UNDERWENT AN UNEVENTFUL PUMP REFILL IN AN OUTPATIENT SETTING. LESS THEN 1 ML OF BACLOFEN WAS OBTAINED FROM THE RESERVOIR; NO LOW-RESERVOIR ALARM WAS NOTED. SHE RETURNED HOME WITHOUT INCIDENT, AND APPROXIMATELY 8 HOURS LATER, DEVELOPED SEVERE PRURITIS AND INCREASED SPASTICITY AND WAS TAKEN TO THE ER. SHE HAD LOW-GRADE FEVER (37.8C), TACHYCARDIA (123 BEATS PER MINUTE), HYPERREFLEXIA, CLONUS, AND INCREASED SPASTICITY, IN ADDITION TO AGITATION AND FEELINGS OF FEAR. THE PUMP WAS INTERROGATED AND FOUND TO BE FUNCTIONING NORMALLY AT THE PREVIOUSLY PROGRAMMED DOSE OF 520 MCG/DAY, VIA SIMPLE CONTINUOUS ADMINISTRATION. RADIOGRAPHIC EVALUATION OF THE PUMP AND CATHETER SHOWED THEY WERE IN PLACE, UNCHANGED FROM PRIOR STUDIES. ORAL BACLOFEN 20 MG AND CYPROHEPTADINE 6 MG WERE GIVEN FOR A DIAGNOSIS OF PRESUMED ITB WITHDRAWAL SYNDROME. SYMPTOMS ABATED DRAMATICALLY WITHIN 1 HOUR: AGITATION DIMINISHED, FEVER AND TACHYCARDIA RESOLVED, AND SPASTICITY, HYPERREFLEXIA, AND INCREASED CLONUS RETURNED TO BASELINE. AFTER TELEPHONE CONSULTATION WITH THE PUMP MANUFACTURER, A PUMP STALL WAS DIAGNOSED. A BOLUS DOSE OF INTRATHECAL BACLOFEN 50 MCG WAS GIVEN PROPHYLACTICALLY VIA THE PUMP. THE PT WAS ADMITTED AND RECEIVED ORAL BACLOFEN 20 MG EVERY 6 HOURS AND CYPROHEPTADINE 6 MG EVERY 6 HOURS FOR SYMPTOMS OF ITB WITHDRAWAL. SHE REMAINED AFEBRILE. AFTER 24 HRS OF OBSERVATION, SHE WAS DISCHARGED HOME WITH A PRESCRIPTION FOR ORAL BACLOFEN AND CYPROHEPTADINE IF NEEDED AFTER CONSULTING WITH A PHYSICIAN. BEFORE DISCHARGE, THE PUMP RESIDUAL VOLUME WAS CHANGED FROM 2ML TO 3ML TO AVOID RECURRENCE OF ITB WITHDRAWAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R PROGRAMMER| CATHETER