BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2344107 · Received November 21, 2011

    Report

    Report Number
    3007566237-2011-09083
    Event Type
    Injury
    Date Received
    November 21, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: RAMSTAD K, JAHNSEN R, LOFTEROD B, SKJELDAL OH. CONTINUOUS INTRATHECAL BACLOFEN THERAPY IN CHILDREN WITH CEREBRAL PALSY - WHEN DOES IMPROVEMENT EMERGE? ACTA PAEDIATR. NOV 2010;99(11):1661-1665. DOI:10.1111/J.1651-2227.2009.01596.X. SUMMARY: THE AUTHORS EXPLORED THE TIMING OF EFFECTS OF INTRATHECAL BACLOFEN THERAPY IN CHILDREN WITH CEREBRAL PALSY. THIRTY-EIGHT PATIENTS WERE ENROLLED FROM (B)(6) 2002 TO (B)(6) 2005. MEDIAN AGE AT PUMP IMPLANTATION WAS (B)(6). REDUCED PAIN AND IMPROVED SLEEP OCCURRED WITHIN 6 MONTHS OF TREATMENT. SOCIAL FUNCTION IMPROVED WITHIN 6 MONTHS AND CONTINUED TO IMPROVE UNTIL 18 MONTHS OF CITB. MOBILITY ALSO IMPROVED, BUT WITH A LATENCY. REPORTABLE EVENT: IN TWO PATIENTS, THE PUMP HAD TO BE REMOVED BECAUSE OF INFECTION AND THE FAMILIES DID NOT WANT ANOTHER PUMP. SURGICAL REVISION OF THE DRUG DELIVERY SYSTEM WAS PERFORMED IN SIX PATIENTS (UNSPECIFIED).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00103 MO Required Intervention