BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3848950 · Received June 4, 2014

    Report

    Report Number
    3007566237-2014-01524
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    November 4, 2013
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DATE REFLECTS THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN; PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    MARGETIS, K., PAPAGEORGIOU, G., GATZONIS, S., POLITIS, K., SIATOUNI, A., SAKAS, D. INTRATHECAL BACLOFEN IMPROVES PSYCHIATRIC SYMPTOMS IN SPASTICITY PATIENTS. JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY. 2014. 34. SUMMARY/REPORTED EVENT: THIS REPORT REFERS TO (B)(6) MALE PATIENT (PATIENT 11) WITH CEREBRAL PALSY OF AFFECTED FOUR LIMBS. PRE MODIFIED ASHWORTH (MA) SPASTICITY SCALE WAS REPORTED AS 1 AND PRE BARRY-ALBRIGHT (BA) SCALE AS 23. PATIENT RECEIVED BACLOFEN (UNKNOWN MANUFACTURER) PROGRAMMABLE FLOW FOR PSYCHIATRIC SYMPTOM OF SPASTICITY AT A DOSE OF 200 UG/ 24 HOURS THROUGH INTRATHECAL. ON AN UNKNOWN DATE, PATIENT EXPERIENCED WOUND DEHISCENCE, CATHETER FRACTURE (2 REOPERATIONS). POST MODIFIED ASHWORTH (MA) SPASTICITY SCALE WAS REPORTED AS 0 AND POST BARRY-ALBRIGHT (BA) SCALE WAS 12. THE AUTHORS CONCLUDED THAT THESE RESULTS SUGGEST THAT SPASTICITY PATIENTS WITH PSYCHOLOGICAL DISTRESS SYMPTOMS SHOULD NOT BE DEPRIVED OF THE ITB OPTION AND HIGHLIGHT THE NEED FOR FURTHER INVESTIGATION OF THE ROLE OF ITB ON PSYCHIATRIC SPECTRUM DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327393 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Required Intervention