BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1913091 · Received August 4, 2010

    Report

    Report Number
    1913091
    Event Type
    Injury
    Date Received
    August 4, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OLD INFARCT, SURROUNDING THE RIGHT SIDED STIMULATOR. PT HAD BILATERAL IMPLANTATION OF DBS ON (B)(6) 2008 AND HAD A GOOD CLINICAL RESPONSE. HE CONTINUES TO BE FOLLOWED FOR ROUTINE CLINIC VISITS. HE WAS SEEN FOR BACLOFEN PUMP REFILL ON (B)(6) 2009 AND HAD NO NEW ISSUES. NEXT VISIT WAS ON (B)(6) 2009, DUE TO PARENT REPORTED ABRUPT ONSET OF INCREASED TONE AND AGITATION. ADJUSTMENTS WERE MADE TO GENERATORS WITH A REDUCTION IN DYSTONIC MOVEMENTS AND A REDUCTION IN MOTOR TONE. HE WAS DISCHARGED FROM CLINIC VISIT IN GOOD CONDITION. NEXT VISIT TOOK PLACE ON (B)(6) 2009 DUE TO WORSENING OF DYSTONIC MOVEMENTS SINCE LAST ROUND OF ADJUSTMENTS. HE WAS FOUND TO HAVE DIFFUSELY INCREASED TONE. ADJUSTMENTS WERE MADE TO GENERATORS. HE SEEMED TO RELAX SOME AND SEEMED MORE COMFORTABLE. AN MRI ON (B)(6) 2009 TO CHECK LEAD PLACEMENT SHOWED A NEW FOCAL ENCEPHALOMALACIA IN THE RIGHT PERI-VENTRICULAR WHITE MATTER JUST ANTERIOR TO THE RIGHT-SIDED DEEP BRAIN STIMULATOR. HE HAS BEEN AND REMAINS ASYMPTOMATIC FROM THIS AREA OF ISCHEMIA SEEN ON MRI.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other INTRATHECAL BACLOFEN VIA BACLOFEN PUMP 400MCG| A DAY| DIAZEPAM 5MG/ML, 2.5ML EVERY 12 HOURS PER GB| MIRALAX 17G PD DAILY