BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6801399 · Received August 17, 2017

    Report

    Report Number
    3007566237-2017-03346
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    September 1, 1992
    Report Date
    August 17, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_PUMP LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE PUMP PRODUCT ID NEU_UNKNOWN_PUMP LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE PUMP PRODUCT ID NEU_UNKNOWN_CATH LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID NEU_UNKNOWN_PUMP LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE PUMP PRODUCT ID NEU_UNKNOWN_CATH LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID NEU_UNKNOWN_PUMP LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE PUMP PRODUCT ID NEU_UNKNOWN_PUMP LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE PUMP PRODUCT ID NEU_UNKNOWN_CATH LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE CATHETER. 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.

    Description of Event or Problem · 1

    MEYTHALER, J.M., STEERS, W.D., TUEL, S.M., CROSS, L.L., HAWORTH, C.S. CONTINUOUS INTRATHECAL BACLOFEN IN SPINAL CORD SPASTICITY. A PROSPECTIVE STUDY. AMERICAN JOURNAL OF PHYSICAL MEDICINE AND REHABILITATION. 1992. 71(6): 321-7. SUMMARY: CONTINUOUS INTRATHECAL INFUSION OF THE WELL KNOWN ANTISPASTIC MEDICATION BACLOFEN WAS EVALUATED IN TEN CONSECUTIVE PATIENTS. ONE YEAR AFTER PUMP IMPLANTATION THE AVERAGE ASHWORTH SCALE FOR MUSCLE TONE DECREASED, COMPARED WITH BEFORE TREATMENT, 2.32 POINTS (P <(><<)> 0.0001), REFLEXES DECREASED 2.22 POINTS (P <(><<)> 0.0001) AND THE SPASM SCORE DECREASED 1.65 POINTS (P <(><<)> 0.0001). THE AVERAGE DOSE INCREASED FROM 92.22 TO 290.95 MICROGRAMS (P <(><<)> 0.0001) BETWEEN THE 1ST MONTH OF TREATMENT AND 1 YR OF TREATMENT. REPORTED EVENTS: 1. A COMPLICATION OF TEMPORARY ATELECTASIS WAS REPORTED. 2. A COMPLICATION OF CATHETER DISRUPTION WAS REPORTED. 3. A COMPLICATION OF AN EXHAUSTED PUMP RESERVOIR WAS REPORTED. 4. ONE PATIENT SUFFERED A SEIZURE APPARENTLY RELATED TO A RAPID WITHDRAWAL FROM INTRATHECAL BACLOFEN AS A RESULT OF CATHETER SEQUEST RATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582391 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other