BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2382642 · Received December 20, 2011

    Report

    Report Number
    3007566237-2011-09298
    Event Type
    Injury
    Date Received
    December 20, 2011
    Report Date
    November 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: FAGBAMI, O. Y., DONATO, A. A. STRIDOR AND DYSPHAGIA ASSOCIATED WITH SUBTHALAMIC NUCLEUS STIMULATION IN PARKINSON DISEASE. JOURNAL OF NEUROSURGERY 2011. 115: 1005-1006. PUBLISHED ONLINE AUGUST 5, 2011. DOI: 10.3171/2011.7.JNS11602. SUMMARY: THE AUTHORS DESCRIBE A PATIENT EXPERIENCING STRIDOR AND DYSPHAGIA WITH CONFIRMED PULMONARY RESTRICTION AND ASPIRATION FOLLOWING SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATOR ADJUSTMENT, WITH A RESOLUTION OF SYMPTOMS AND SIGNS WHEN THE STIMULATOR WAS SWITCHED OFF. REPORTED EVENT: THE PATIENT PRESENTED WITH AN 8-MONTH HISTORY OF A PAROXYSMAL, NON-PRODUCTIVE COUGH. DEVICE SETTINGS WERE: LEFT STN, UNIPOLAR STIMULATION, 90MCS PULSE WIDTH, 1.6V, 130 HZ; RIGHT STN, UNIPOLAR STIMULATION, 60MCS PULSE WIDTH, 1.6V, 130 HZ. IT WAS NOTED THAT HIS COUGH HAD BECOME ACUTELY WORSE FOLLOWING SEVERAL STIMULATOR ADJUSTMENTS AND THAT SYMPTOMS PARTIALLY IMPROVED WITH FURTHER ADJUSTMENT OF THE SETTINGS. NONETHELESS, HE CONTINUED TO BE SHORT OF BREATH BOTH AT REST AND ON EXERTION. IN ADDITION, HE NOTED INTERMITTENT DIFFICULTY DRINKING LIQUIDS, WHICH CAME ON FOLLOWING THROAT SPASMS AND WAS ACCOMPANIED BY COUGH PAROXYSMS. HIS COUGH PERSISTED DESPITE SEVERAL COURSES OF ANTIBIOTICS, INHALERS, STEROIDS, AND COUGH SUPPRESSANTS OVER THE PAST 3 MONTHS. EXAMINATION WAS UNREVEALING EXCEPT FOR MILD STRIDOR AND TACHYPNEA. FLUOROSCOPIC SWALLOWING EVALUATION CONFIRMED THE ASPIRATION OF THIN LIQUIDS, WHILE PULMONARY FUNCTION TESTING SHOWED A MILD RESTRICTIVE PATTERN WITHOUT ABNORMALITY OF THE FLOW VOLUME LOOP. DIRECT LARYNGOSCOPY REVEALED NO OBSTRUCTION AND NORMAL VOCAL CORDS. IT WAS SUSPECTED THAT THE PATIENT HAD DYSTONIA OF THE MUSCLES OF HIS UPPER AIRWAY, MANIFESTED BY STRIDOR, SWALLOWING DYSFUNCTION, AND ASPIRATION, WHICH IMMEDIATELY RESOLVED WITH SWITCHING OFF THE STIMULATOR AND IMPROVED WITH ADJUSTMENT IN THE STIMULATOR SETTINGS. THE PATIENT NOTED SUBJECTIVE IMPROVEMENT IN HIS COUGH AND SWALLOWING SYMPTOMS BY ABOUT 80%, WITH NO FURTHER COUGH PAROXYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention