BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2088635 · Received May 9, 2011

    Report

    Report Number
    3004209178-2011-03355
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    January 1, 2008
    Report Date
    February 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: ALTERMAN ET AL. "DEEP BRAIN STIMULATION FOR TORSION DYSTONIA IN CHILDREN" CHILDS NERV SYST. 2007; 23(9): 1003-1040. SUMMARY: THE ARTICLE DESCRIBES A STUDY INVOLVING 19 PATIENTS BEING TREATED WITH DEEP BRAIN STIMULATION (DBS) OF THE INTERNAL GLOBUS PALLIDUS (GPI) FOR SYMPTOMS RELATED TO DYSTONIA. A NUMBER OF COMPLICATIONS WERE REPORTED. FOUR PATIENTS DEVELOPED PERIOPERATIVE INFECTIONS RESULTING IN 5 DEVICES BEING REMOVED. ALL PATIENTS WERE TREATED WITH ANTIBIOTICS AND HAD SUBSEQUENTLY RECEIVED NEW IMPLANTS AFTER THE INFECTIONS RESOLVED. REPORTABLE EVENT: ADDITIONAL INFORMATION WAS RECEIVED AND REVIEWED; THE AUTHOR REPORTS THAT ONE OF THE PATIENTS WHO DEVELOPED A PERIOPERATIVE INFECTION WAS A (B)(6) PATIENT WITH GENERALIZED DYSTONIA WHO HAD THEIR LEFT IPG AND EXTENSION EXPLANTED ON (B)(6) 2004 DUE TO THE INFECTION. SEE LITERATURE ARTICLE WITH MFR REPORT# 2182207-2008-00309.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention IMPLANTED:| LOT# NFW121778H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU043086V| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU043084V| EXPLANTED: