BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1885197 · Received October 25, 2010

    Report

    Report Number
    3007566237-2010-08378
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER 3 IPG CHANGES IN 13 MONTHS ON THE LEFT SIDE, A KINETRA (7428) IPG WAS INSERTED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: ALCINDOR D, OH MY, BASER S, ANGLE C. CHENG BC, WHITING D. STIMULATION OF THE GLOBUS PALLIDU INTERNUS IN A PATIENT WITH DYT1-POSITIVE PRIMARY GENERALIZED DYSTONIA: A 10-YEAR FOLLOW-UP. NEUROSURG FOCUS. AUG 2010; 29(2):E16. SUMMARY: IN THIS CASE REPORT, THE AUTHORS DESCRIBE A (B)(6) OLD MAN WITH DYT1-POSITIVE DYSTONIA WHO UNDERWENT BILATERAL GPI DBS AND REPORT THE 10-YEAR SAFETY AND EFFICACY DATA. THE PATIENT HAD 10 LEFT IPG CHANGES ON THE MORE SYMPTOMATIC SIDE DUE TO HIGHER VOLTAGE NEEDS AND 5 IPG CHANGES ON THE RIGHT OVER 10 YEARS. WITHIN 3 MONTHS OF STAGE 1 SURGERY, THE PATIENT EXPERIENCED A DRAMATIC IMPROVEMENT; THEY WERE ABLE TO RETURN TO SCHOOL AND FUNCTION INDEPENDENTLY. MINOR SYMPTOMS EXPERIENCED INCLUDED MILD DYSARTHRIA AND A SUBTLE RIGIDITY WHILE WALKING, NONE OF WHICH IMPEDES DAILY ACTIVITIES. REPORTABLE EVENT: THERE WERE NO SIGNIFICANT COMPLICATIONS, NEUROLOGICAL DEFICITS, INFECTION/EROSION, OR SYSTEM MALFUNCTIONS. HOWEVER, 4 YEARS AFTER INITIAL IPG PLACEMENT, THE PT HAD INCREASED RIGIDITY AND MORE CRAMPING ON THE RIGHT SIDE WITH THE DEVELOPMENT OF DIAPHORESIS. IN THE LEFT SUBCLAVICULAR IPG THERE WERE EXTREMELY HIGH IMPEDANCES, AND CHEST RADIOGRAPHY REVEALED DISCONNECTION OF THAT GENERATOR. AFTER REVISION SURGERY, THESE WORSENING SYMPTOMS RESOLVED AND THE PATIENT HAS HAD NO FURTHER EPISODES OF SYMPTOM RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| LEAD: MODEL 3387, LOT # UNK| LOT# UNK| LEAD: MODEL 3387, LOT# UNK