BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 5419411 · Received February 9, 2016

    Report

    Report Number
    3004209178-2016-01770
    Event Type
    Death
    Date Received
    February 9, 2016
    Report Date
    April 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 37603 (LOT # NLB722983H) SHOWED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED THAT CONCLUSION CODE DOES NOT APPLY TO THIS EVENT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED THE PATIENT WAS HAVING AN MRI SINCE THEY HAD CONFUSION SINCE SURGERY AND THEY WERE LOOKING FOR A POSSIBLE STROKE. THE HCP DID NOT KNOW WHAT TYPE OF SURGERY THE PATIENT HAD OR IF THE SURGERY WAS RELATED TO THE DEEP BRAIN STIMULATION (DBS) OR NOT. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN CHECKED AND THE INS WAS TURNED OFF. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS. NO CAUSE, MRI RESULTS, ACTIONS/INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT #3004209178-2016-01769.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE CONSUMER DIED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76458 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O