BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2140952 · Received June 21, 2011

    Report

    Report Number
    3007566237-2011-04631
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    September 29, 2009
    Report Date
    August 5, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COPY OF THE ARTICLE CAN BE OBTAINED AT (B)(6). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: SERVELLO D, SASSI M, BRAMBILLA A, DEFENDI S, PORTA M. LONG-TERM POST-DEEP STIMULATION MANAGEMENT OF A SERIES OF 36 PTS AFFECTED WITH REFRACTORY GILLES DE LA TOURETTE SYNDROME. NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE. 2010;13(3):187-194. DOI: 10.1111/J.1525-1403.2009.00253.X. SUMMARY: THE AUTHORS REPORT ON A LARGE SERIES OF PTS WITH SEVERE TOURETTE'S SYNDROME TREATED WITH DEEP BRAIN STIMULATION (DBS). THIRTY SIX PTS WERE INCLUDED SINCE (B)(6) 2004. FOLLOW-UP EVALUATIONS WERE PERFORMED EVERY THREE MONTHS. THE AUTHORS INDICATE A SIGNIFICANT IMPROVEMENT IN ALL THE EVALUATION SCALES CONSIDERED TIC MANIFESTATIONS AND COMORBID FEATURES. REPORTABLE EVENTS: ONE PT REQUIRED THE REPOSITIONING OF TWO LEADS. NO OTHER INFO WAS PROVIDED. ONE PT EXPERIENCED SIGNS OF SUBCUTANEOUS INFECTION AT THE PULSE GENERATOR ABDOMINAL POUCH AND ALONG THE EXTENSION CABLES BECAUSE OF DIASTASIS. THE ENTIRE DBS SYSTEM WAS REMOVED. IT WAS INDICATED IN THE ARTICLE THAT THE DIASTASIS WAS DUE MAINLY TO THE SELF-REPORTED COMPULSION TOWARD REPETITIVE TOUCHING OF THE SURGICAL WOUND. TWO PTS REQUIRED REVISION OF THEIR SURGICAL WOUNDS ALONG THE EXTENSION CABLES SUBCUTANEOUS DECURRENCE BECAUSE OF DIASTASIS. IT WAS INDICATED IN THE ARTICLE THAT THE DIASTASIS WAS DUE MAINLY TO THE SELF-REPORTED COMPULSION TOWARD REPETITIVE TOUCHING OF THE SURGICAL WOUND. TWO PTS REQUIRED SURGICAL REVISION OF THE SUBCUTANEOUS PULSE GENERATOR POUCH BECAUSE OF INFECTION. THE PULSE GENERATORS WERE REPLACED AND THE PTS WERE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT # UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT # UNK| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL UNK, LOT # UNK| EXTENSION: MODEL UNK, LOT # UNK