BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6915469 · Received October 5, 2017

    Report

    Report Number
    3007566237-2017-04187
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    June 21, 2017
    Report Date
    October 4, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_PUMP, SERIAL# UNKNOWN, PRODUCT TYPE: PUMP. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    YOON, Y.K, LEE, K.C., CHO, H.E., CHAE, M., CHANG, J.W., CHANG, W.S., CHO, S. OUTCOMES OF INTRATHECAL BACLOFEN THERAPY IN PATIENTS WITH CEREBRAL PALSY AND ACQUIRED BRAIN INJURY. MEDICINE. 2017. 96:34 (E7472). DOI: 10.1097/MD.0000000000007472. INTRATHECAL BACLOFEN (ITB) HAS BEEN KNOWN TO REDUCE SPASTICITY WHICH DID NOT RESPOND TO ORAL MEDICATIONS AND BOTULINUM TOXIN TREATMENT. HOWEVER, FEW RESULTS HAVE BEEN REPORTED COMPARING THE EFFECTS OF ITB THERAPY IN PATIENTS WITH CEREBRAL PALSY (CP) AND ACQUIRED BRAIN INJURY. THIS STUDY AIMED TO INVESTIGATE BENEFICIAL AND ADVERSE EFFECTS OF ITB BOLUS INJECTION AND PUMP THERAPY IN PATIENTS WITH CP AND TO COMPARE OUTCOMES TO PATIENTS WITH ACQUIRED BRAIN INJURY SUCH AS TRAUMATIC BRAIN INJURY AND HYPOXIC BRAIN INJURY. ITB TEST TRIALS WERE PERFORMED IN 37 PATIENTS (19 CP AND 18 ACQUIRED BRAIN INJURY). BASED ON AMBULATORY FUNCTION, CP PATIENTS WERE DIVIDED INTO 2 GROUPS: 11 PATIENTS WITH NONAMBULATORY CP AND 8 PATIENTS WITH AMBULATORY CP. CHANGE OF SPASTICITY WAS EVALUATED USING THE MODIFIED ASHWORTH SCALE. ADDITIONAL POSITIVE OR NEGATIVE EFFECTS WERE ALSO EVALUATED AFTER ITB BOLUS INJECTION. IN PATIENTS WHO RECEIVED ITB PUMP IMPLANTATION, OUTCOMES OF SPASTICITY, SUBJECTIVE SATISFACTION AND ADVERSE EVENTS WERE EVALUATED UNTIL 12 MONTHS POST-TREATMENT. AFTER ITB BOLUS INJECTION, 32 PATIENTS (86.5%) (CP 84.2% VERSUS ACQUIRED BRAIN INJURY 88.9%) SHOWED A POSITIVE RESPONSE OF REDUCING SPASTICITY. HOWEVER, 8 PATIENTS WITH CP HAD NEGATIVE ADVERSE EFFECTS. PARTICULARLY, 3 AMBULATORY CP PATIENTS SHOWED STANDING IMPAIRMENT AND 1 AMBULATORY CP PATIENT SHOWED IMPAIRED GAIT PATTERN SUCH AS FOOT DROP BECAUSE OF EXCESSIVE REDUCTION OF LOWER EXTREMITY MUSCLE TONE. AMBULATORY CP PATIENTS RECEIVED ITB PUMP IMPLANTATION LESS THAN PATIENTS WITH ACQUIRED BRAIN INJURY AFTER ITB TEST TRIALS (P=.003 BY A CHI-SQUARED TEST). AFTER THE PUMP IMPLANTATION, SPASTICITY WAS SIGNIFICANTLY REDUCED WITHIN 1 MONTH AND THE EFFECT MAINTAINED FOR 12 MONTHS. SEVENTEEN PATIENTS OR THEIR CAREGIVERS (73.9%) WERE VERY SATISFIED, WHEREAS 5 PATIENTS (21.7%) SUFFERED FROM ADVERSE EVENTS SHOWED NO SUBJECTIVE SATISFACTION. IN CONCLUSION, ITB THERAPY WAS EFFECTIVE IN REDUCING SPASTICITY IN PATIENTS WITH CP AND ACQUIRED BRAIN INJURY. BEFORE ITB PUMP IMPLANTATION, IT SEEMS NECESSARY TO PERFORM THE ITB BOLUS INJECTION TO VERIFY BENEFICIAL EFFECTS AND ADVERSE EFFECTS ESPECIALLY IN AMBULATORY CP. REPORTED EVENTS: 1. ONE PATIENT WITH TRAUMATIC BRAIN INJURY EXPERIENCED AN ADVERSE EVENT OF WITHDRAWAL SYMPTOMS AND A CATHETER DISCONNECTION. THE EVENT REQUIRED REVISION MANAGEMENT BY SURGICAL OPERATION. 2. ONE PATIENT WITH TRAUMATIC BRAIN INJURY EXPERIENCED AN ADVERSE EVENT OF DROWSINESS. THE PATIENT HAD PERSISTENT DROWSINESS AND EVENTUALLY WANTED TO REMOVE THE ITB PUMP. 3. ONE PATIENT WITH HYPOXIC BRAIN INJURY EXPERIENCED AN ADVERSE EVENT OF A WOUND INFECTION. THE EVENT REQUIRED REVISION MANAGEMENT BY SURGICAL OPERATION. 4. ONE PATIENT WITH HYPOXIC BRAIN INJURY EXPERIENCED AN ADVERSE EVENT OF WOUND DEHISCENCE AND A CATHETER DISCONNECTION. THE EVENT REQUIRED REVISION MANAGEMENT BY SURGICAL OPERATION. 5. ONE PATIENT WITH NONAMBULATORY CP EXPERIENCED AN ADVERSE EVENT OF CEREBROSPINAL FLUID (CSF) LEAKAGE. THE EVENT REQUIRED REVISION MANAGEMENT BY SURGICAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696718 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention