BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6139005 · Received December 1, 2016

    Report

    Report Number
    3007566237-2016-04221
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 4, 2016
    Report Date
    December 8, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE ADDITION INFORMATION RECEIVED, IT WAS DETERMINED THAT PATIENT (B)(4) NO LONGER APPLY AS IT WAS STATED THEY WERE UNRELATED TO THE DEVICE/THERAPY AND PROCEDURE. ADDITIONALLY, PATIENT CODE (B)(4) NOW APPLIES AS IT WAS DETERMINED TO BE MORE APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS FIELD WAS UPDATED TO REFLECT AN ERROR MADE IN THE PREVIOUS SUPPLEMENTAL.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REITERATED THAT THE PATIENT EXPERIENCED HEMIPARESIS ON THE RIGHT SIDE WHAT RESULTED IN HOSPITALIZATION FROM (B)(6) 2016. IT WAS ALSO SUSPECTED THAT THE PATIENT EXPERIENCED A STROKE IN THE VERTEBROBASILAR REGION WITH SYMPTOMS OF HEMIPARESIS ON THE RIGHT AND FACIAL PARESIS ON THE LEFT. A CCT SCAN WAS PERFORMED ON (B)(6) 2016 AND REVEALED NO ISCHEMIA. THE PATIENT WAS RECEIVING THERAPY WITH AAS 100MG/D AND FLUVASTATIN 30 MG/D. NO FURTHER DIAGNOSTICS WERE PERFORMED AS THE PATIENT WAS TRANSFERRED TO NEUROLOGY ON (B)(6) 2016. AN MRI WAS THEN PERFORMED ON (B)(6) 2016 AND REVEALED NO CEREBRAL GENESIS FOR HEMIPARESIS. HOWEVER, ISOLATED PERONEAL NERVE PALSY ON THE RIGHT SIDE WAS DIAGNOSED. IT WAS CONFIRMED THAT THE HOSPITAL DETERMINED THAT THERE WAS NO RELATEDNESS BETWEEN THE REPORTED EVENT AND THE MEDICAL DEVICE OR MEDICAL PROCEDURE (DEVICE IMPLANT). IT WAS CONFIRMED THAT THE FIRST USE OF THE DEVICE WAS ON (B)(6) 2016 AND THE LAST USE PRIOR TO THE SERIOUS ADVERSE EVENT (SAE) WAS ON (B)(6) 2016; THE DEVICE WAS IMPLANTED ON (B)(6) 2016.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REITERATED THAT THE PATIENT EXPERIENCED HEMIPARESIS ON THE RIGHT SIDE WHAT RESULTED IN HOSPITALIZATION FROM (B)(6) 2016. IT WAS ALSO SUSPECTED THAT THE PATIENT EXPERIENCED A STROKE IN THE VERTEBROBASILAR REGION WITH SYMPTOMS OF HEMIPARESIS ON THE RIGHT AND FACIAL PARESIS ON THE LEFT. A CCT SCAN WAS PERFORMED ON (B)(6) 2016 AND REVEALED NO ISCHEMIA. THE PATIENT WAS RECEIVING THERAPY WITH AAS 100MG/D AND FLUVASTATIN 30 MG/D. NO FURTHER DIAGNOSTICS WERE PERFORMED AS THE PATIENT WAS TRANSFERRED TO NEUROLOGY ON (B)(6) 2016. AN MRI WAS THEN PERFORMED ON (B)(6) 2016 AND REVEALED NO CEREBRAL GENESIS FOR HEMIPARESIS. HOWEVER, ISOLATED PERONEAL NERVE PALSY ON THE RIGHT SIDE WAS DIAGNOSED. IT WAS CONFIRMED THAT THE HOSPITAL DETERMINED THAT THERE WAS NO RELATEDNESS BETWEEN THE REPORTED EVENT AND THE MEDICAL DEVICE OR MEDICAL PROCEDURE (DEVICE IMPLANT). THE ISSUE WAS RESOLVED WITHOUT SEQUELAE. IT WAS CONFIRMED THAT THE FIRST USE OF THE DEVICE WAS ON (B)(6) 2016 AND THE LAST USE PRIOR TO THE SERIOUS ADVERSE EVENT (SAE) WAS ON (B)(6) 2016; THE DEVICE WAS IMPLANTED ON (B)(6) 20163. THE PATIENT'S MEDICAL HISTORY THAT WAS NO PREVIOUSLY REPORTED INCLUDES: ISOLATED PERONEAL NERVE PALSY (RIGHT). THE PATIENT'S CONCOMITANT MEDICATIONS THAT WERE NOT PREVIOUSLY REPORTED INCLUDES: QUEHAPIN, "ALL", AND SIMVASTATIN.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL FROM A CLINICAL STUDY REPORTED THE PATIENT HAD EXPERIENCED HEMIPARESIS ON THE RIGHT SIDE ON (B)(6) 2016. DUE TO THE HEMIPARESIS THE PATIENT WAS TRANSFERRED TO THE NEUROLOGY DEPARTMENT AT THE HOSPITAL. THREE DAYS LATER, THE PATIENT WAS HOSPITALIZED AT THE STROKE UNIT AND THE HOSPITALIZATION WAS TO BE CONTINUED DUE TO A STROKE. PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR BODY FUNCTION WAS NOTED AND PATIENT STATUS WAS ALIVE-WITH INJURY. THE RELATEDNESS OF THE EVENT TO THE DEVICE WAS CONSIDERED UNDETERMINED, BUT NO DEVICE ISSUES WERE REPORTED. THE EVENT WAS CONSIDERED NOT RELATED TO THE IMPLANT PROCEDURE. NO SURGICAL INTERVENTION HAD OCCURRED AND IT WAS UNKNOWN IF ANY WERE PLANNED. THE EVENT WAS SEVERE AND ONGOING. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES CHOREA HUNTINGTON, HYPERKINESIA, HYPERTENSION, GASTRITIS, AND DEPRESSION AND RELEVANT CONCOMITANT MEDICATION INCLUDES METOPROLOL, AMLODIPINE, PANTOPRAZOLE, TIAPRIDEX, SEROQUEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790278 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O