BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROGRAMMABLE DRUG DELIVERY DEVICES

    MDR report key: 926824 · Received October 11, 2007

    Report

    Report Number
    2182207-2007-03206
    Event Type
    Other
    Date Received
    October 11, 2007
    Report Date
    September 21, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP IS IN PROCESS TO ESTABLISH SPECIFIC EVENT DETAILS AND ADD'L INFO WILL BE SUBMITTED WHEN AVAILABLE. THE PUMP AND CATHETER MFRS WERE NOT PROVIDED.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: BEN SMALL D, HUGERON C, ET AL. "PRURITUS AFTER INTRATHECAL BACLOFEN WITHDRAWAL: A RETROSPECTIVE STUDY" ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION, 2005; 86 (3): 494-7. TEN SPINAL CORD INJURY PATIENTS EXPERIENCED CESSATION OF THERAPY. THE ARTICLE DESCRIBES THE RESULTS OF A RETROSPECTIVE DESIGNED TO DETERMINE THE FREQUENCY OF PRURITUS AFTER INTRATHECAL BACLOFEN (ITB) WITHDRAWAL AND TO THE PATHOPHYSIOLOGY OF THIS SYMPTOM. PATIENTS STUDIED WERE RECEIVING INTRATHECAL BACLOFEN TREATMENT USING AN IMPLANTABLE INFUSION PUMP. THE STUDY IDENTIFIED 23 PATIENTS THAT EXPERIENCED BACLOFEN WITHDRAWAL. TEN OF THE 23 EXPERIENCED PRURITUS. THE CAUSES OF EACH WITHDRAWAL EXPERIENCE WERE ONLY REPORTED IN GENERAL TERMS AND NOT SPECIFIC TO THE 23 PATIENTS. CAUSES INCLUDED: CATHETER AND PUMP RELATED PROBLEMS ALONG WITH PUMP BATTERY DEPLETION AND FAILURE TO REFILL PUMP AT THE APPROPRIATE TIME. ALL 23 PATIENTS EXPERIENCED TREATMENT DEPRIVATION THAT CONSISTENTLY INDUCED A BRUTAL AND SEVERE INCREASE IN SPASTICITY OR PAIN. IN ADDITION, 10 PATIENTS EXHIBITED PRURITUS. IN GENERAL, CATHETER AND PUMP RELATED PROBLEMS ALONG WITH PUMP BATTERY DEPLETION AND FAILURE TO REFILL PUMP AT THE APPROPRIATE TIME WERE LISTED AS WITHDRAWAL CAUSES. PATIENT SPECIFIC INFO ON WITHDRAWAL CAUSE WAS NOT PROVIDED. REPORTABLE EVENTS: BACLOFEN WITHDRAWAL WITH PRURITIS: PUMP (N=5), CATHETER (N=5) FIVE PATIENTS WITH SCI. PUMP (N=1), CATHETER (N=1) ONE PATIENT WITH CP. PUMP (N=1), CATHETER (N=1) ONE PATIENT WITH HSP. PUMP (N=1), CATHETER (N=1) ONE PATIENT WITH CEL. PUMP (N=1), CATHETER (N=1) ONE PATIENT WITH TBI. PUMP (N=1), CATHETER (N=1) ONE STROKE PATIENT. BACLOFEN WITHDRAWAL WITHOUT PRURITIS: PUMP (N=5), CATHETER (N=5) FIVE PATIENTS WITH SCI. PUMP (N=4), CATHETER (N=4) ONE PATIENT WITH MS. PUMP (N=1), CATHETER (N=1) ONE PATIENT WITH CP. PUMP (N=1), CATHETER (N=1) ONE PATIENT WITH HSP. PUMP (N=2), CATHETER (N=2) ONE PATIENT WITH TBI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMABLE DRUG DELIVERY DEVICES LKK MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR