BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1059680 · Received June 12, 2008

    Report

    Report Number
    2182207-2008-03154
    Event Type
    Injury
    Date Received
    June 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: SOBSTYL M, ZABEK M, KOZIARA H, DZIERCZEKI S. CHRONIC BILATERAL PALLIDAL STIMULATION IN A PT WITH DYT-1 POSITIVE PRIMARY GENERALIZED DYSTONIA. A LONG-TERM FOLLOW-UP STUDY. NEUROL NEUROCHIR POL 2008;42(1):50-54.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: SOBSTYL M, ZABEK M, KOZIARA H, DZIERCZEKI S. CHRONIC BILATERAL PALLIDAL STIMULATION IN A PT WITH DYT-1 POSITIVE PRIMARY GENERALIZED DYSTONIA. A LONG-TERM FOLLOW-UP STUDY. NEUROL NEUROCHIR POL 2008;42(1):50-54. THE AUTHORS PRESENT THE EFFECTIVENESS OF BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) STIMULATION IN A MALE PT WITH PRIMARY DYT-I POSITIVE DYSTONIA. PHARMACOTHERAPY COMPLETELY FAILED TO CONTROL GENERALIZED DYSTONIC MOVEMENTS. THE PT WAS REFERRED FOR SURGICAL TREATMENT AND UNDERWENT BILATERAL IMPLANTATION OF DBS LEADS IN THE GPI. FOLLOW-UP WAS FOR 5 YEARS; ALL STIMULATION-INDUCED SIDE EFFECTS WERE REVERSIBLE. REPORTABLE EVENT: PT DEVELOPED STERILE SEROMAS AT THE IPG SITE, THE SEROMAS REQUIRED REPEATED PROCEDURES -- FOLLOWING 2 YRS THE PT GAINED THE PREVIOUS BENEFIT, UNEVENTFUL, PT IS ABLE TO WALK WITH A CANE IS NEARLY COMPLETELY FREE OF DISABLING RETROCOLLIS AND TRUNCAL DYSTONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention EXTENSION MODEL UNK N=2| SOLETRA MODEL 7426 N=1| LEAD MODEL 3387 N=2| PROGRAMMER MODEL UNK N=1