BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1051095 · Received May 22, 2008

    Report

    Report Number
    2182207-2008-02751
    Event Type
    Injury
    Date Received
    May 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: VAGEFI MR, LIN CC, MCCANN JD, ANDERSON RL. EXACERBATION OF BLEPHAROSPASM ASSOCIATED WITH CRANIOCERVICAL DYSTONIA AFTER PLACEMENT OF BILATERAL GLOBUS PALLIDUS INTERNUS DEEP BRAIN STIMULATOR. MOV DISORD 2008;23(3): 454-456. TO REPORT A CASE OF EXACERBATION OF BLEPHAROSPASM AFTER BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATOR (DBS) PLACEMENT. A MALE PRESENTED AFTER BILATERAL GPI DBS PLACEMENT FOR BLEPHAROSPASM AND CRANIOCERVICAL DYSTONIA. OVER THE COURSE OF 7 MONTHS, HE DID HAVE SOME IMPROVEMENT OF LOWER FACIAL SPASMS AND SWALLOWING, AS WELL AS, WITH JAW AND NECK PAIN. HOWEVER, BLEPHAROSPASM SYMPTOMS WERE WITH WORSENING EYELID SPASMS AND ASSOCIATED APRAXIA OF LID OPENING (ALO). NUMEROUS ATTEMPTS TO ADJUST DBS PARAMETERS WERE INEFFECTIVE. CONSEQUENTLY, BILATERAL UPPER EYELID MYECTOMY WAS PERFORMED. MYECTOMY SURGERY WAS FREE OF COMPLICATIONS. THE PATIENT HAD SIGNIFICANT IMPROVEMENT OF BLEPHAROSPASM AND ALO. REPORTABLE EVENT: EXACERBATION OF BLEPHAROSPASM SEEN IN THIS PATIENT IS LIKELY A RESULT OF A STIMULATION RELATED PHENOMENA PARTICULARLY SINCE SYMPTOMS WERE CLEARLY WORSE WITH HIGHER VOLTAGE AND FREQUENCY SETTINGS AND RETURNED TO BASELINE ONCE THE DEVICE WAS TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other IMPLANTABLE STIMULATOR MODEL=UNK N=1| PROGRAMMER UNK N=1| EXTENSION MODEL UNK N=2| LEAD MODEL UNK N=1