BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2098704 · Received May 18, 2011

    Report

    Report Number
    3007566237-2011-03634
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    December 20, 2009
    Report Date
    April 16, 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).

    Description of Event or Problem · 1

    LITERATURE: ALLERT N, LEHRKE R, STRUM V, VOLTMANN J. SECONDARY FAILURE AFTER 10 YEARS OF PALLIDAL NEUROSTIMULATION IN A PATIENT WITH ADVANCED PARKINSON'S DISEASE. J NEURAL TRANSM. 2010; 117(3): 349-351. SUMMARY: THIS ARTICLE DISCUSSES A (B)(6) FEMALE PATIENT WITH INITIAL GOOD RESPONSE TO BILATERAL INTERNAL GLOBUS PALLIDAL (GPI) NEUROSTIMULATION WHO DEVELOPED A SECONDARY AFTER 10 YEARS OF TREATMENT. THE FAILURE WAS THEN SUCCESSFULLY REVERSED BY REIMPLANTING THE LEADS INTO THE SUBTHALAMIC NUCLEUS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED. APPROX 5 YEARS INITIAL (GPI) IMPLANTATION, THE PATIENT GRADUALLY BEGAN TO EXPERIENCE A RETURN OF HYPOKINETIC AND DYSKINETIC FLUCTUATIONS. BY 8 YEARS OF GPI STIMULATION, THE MEDICATION OFF/STIMULATION ON STATES WAS COMPLICATED BY OFF-DYSTONIA OF THE LEGS, LEFT ARM AND FACIAL MUSCLES INCLUDING INTERMITTENT BLEPHAROSPASM AND EYELID APRAXIA. THE PATIENT ALSO SUFFERED FROM SIGNIFICANT PSYCHIATRIC NON-MOTOR FLUCTUATIONS WITH OFF-RELATED PANIC ATTACKS, ANXIETY AND DEPRESSION WHICH HAD BEEN PRESENT TO A LESSER EXTENT PRIOR TO SURGERY. DURING THE MEDICATION ON/STIMULATION ON STATE, THE PATIENT EXPERIENCED CHOREIFORM AND PAINFUL DYSKINESIAS, RESULTING IN THE PATIENT EVENTUALLY TAKING HOURLY ORAL MEDICATION. THE PATIENT ALSO EXPERIENCED SLEEP DISTURBANCES BECAUSE OF NIGHT TIME OFF SYMPTOMS WITH AN INABILITY TO TURN IN BED AND PAINFUL OFF-DYSKINESIA. IMMEDIATELY FOLLOWING THE FOURTH ROUTINE REPLACEMENT OF THE RIGHT SIDE NEUROSTIMULATOR, THE STIMULATION HAD TO BE TURNED DOWN DUE TO ACUTE STIMULATION-INDUCED DYSARTHRIA AND FACIAL MUSCLE CONTRACTION, WHICH RESULTED IN AN ACCELERATION OF FLUCTUATIONS AND OFF SYMPTOMS. IMPEDANCE MEASUREMENTS SUGGESTED A SHORT CIRCUIT BETWEEN CONTACTS 0 AND 1. THE PATIENT WAS HOSPITALIZED TO EVALUATE THE NEED FOR SURGERY, BUT REPROGRAMMING RESULTED IN CLINICAL EFFICACY EQUAL TO THAT PRIOR TO THE FOURTH SURGERY SO NO SURGERY WAS PERFORMED. PROGRESSION OF MOTOR FLUCTUATIONS AND DYSKINESIA THEN CONTINUED W/O THE ADDED ACCELERATION. TEN YEARS AFTER INITIAL STIMULATOR PLACEMENT, THE PATIENT UNDERWENT REPLACEMENT SURGERY TO CHANGE THE AREA OF STIMULATION TO THE SUBTHALAMIC NUCLEUS BECAUSE THE DISABILITIES HAD BECOME "INTOLERABLE." FOLLOWING REPLACEMENT SURGERY, THE PATIENT'S MOTOR SYMPTOMS AND DYSKINESIA IMPROVED WITH COMPLETE SUPPRESSION OF FLUCTUATIONS. THE PATIENT'S MOTOR SCORE, OFF-DYSTONIA OF THE EXTREMITIES, ACTIVITIES OF DAILY LIVING, NON-MOTOR SYMPTOMS AND SLEEP IMPROVED AND REMAINED GOOD AT THE LAST FOLLOW-UP VISIT 18 MONTHS LATER. THE EYELID APRAXIA PERSISTED BUT COULD BE CONTROLLED BY MEDICATION.

    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 49 YR Hospitalization| R IMPLANTABLE PULSE GENERATOR: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK