BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2070140 · Received April 21, 2011

    Report

    Report Number
    3007566237-2011-02997
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    August 23, 2010
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. 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: HARIDAS A, TAGLIATI M, OSBORN I, ET AL. PALLIDAL DEEP BRAIN STIMULATION FOR PRIMARY DYSTONIA IN CHILDREN. NEUROSURGERY. MAR 2011; 68(3):738-743. SUMMARY: THE AUTHORS DESCRIBE THE LONG-TERM RESPONSES TO PALLIDAL DEEP BRAIN STIMULATION (DBS) OF A CONSECUTIVE SERIES OF 22 PEDIATRIC PTS (16 MALES AND 6 FEMALES) WITH PRIMARY GENERALIZED DYSTONIA (PGD). THEY CONDUCTED A RETROSPECTIVE CHART REVIEW OF 22 CONSECUTIVE PGD PTS, LESS THAN (B)(6) TREATED BY ONE DBS TEAM OVER AN 8-YEAR PERIOD. ONE PT WAS TREATED UNILATERALLY AND 21 BILATERALLY. THE AUTHORS CONCLUDED THAT PALLIDAL DBS IS A SAFE AND EFFECTIVE TREATMENT FOR PGD IN PTS LESS THAN 21 YEARS OF AGE. NONE OF THE PTS EXPERIENCED AN INTRACEREBRAL HEMORRHAGE OR ADVERSE NEUROLOGICAL EVENT RELATED TO THE SURGERY. REPORTABLE EVENTS: THREE PTS (4 LEADS) EXPERIENCED AN INFECTION 4 TO 6 WEEKS AFTER THE DEVICE WAS IMPLANTED; ALL CASES INVOLVED (B)(6). EACH INFECTION WAS TREATED WITH DEVICE REMOVAL AND A 3 TO 6 WEEK COURSE OF ANTIBIOTICS. ONE PT EXPERIENCED A LEAD FRACTURE; THE LEAD WAS REPLACED DURING THE FIRST YEAR OF THERAPY. ONE PT EXPERIENCED A SUBOPTIMAL LEAD POSITION THAT REQUIRED REPLACEMENT DURING THE FIRST YEAR OF THERAPY. TWO PTS (2 LEADS) DESIRED AN IMPROVED CLINICAL RESPONSE AND HAD THEIR LEADS REPLACED WITHIN THE FIRST YEAR OF THERAPY. ONE PT EXPERIENCED AN EXTENSION CABLE FRACTURE WHICH WAS REPLACED. ONE PT HAD A VENOUS AIR EMBOLUS DURING SURGERY, WHICH FORCED THE AUTHORS TO ABORT THE INITIAL PROCEDURE BEFORE ANY ELECTRODES WERE IMPLANTED. THE PT EXPERIENCED NO ADDITIONAL ADVERSE EFFECTS AND RECOVERED RAPIDLY AFTER HIS INCISION WAS CLOSED. THE PT WAS ABLE TO RETURN 1 MONTH LATER FOR SUCCESSFUL BILATERAL LEAD IMPLANTATION.

    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 16 YR Required Intervention IMPLANTABLE NEURO STIMULATOR: MODEL 7426, LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# UNKNOWN| LEAD: MODEL 3387, LOT# UNKNOWN