BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7226149 · Received January 29, 2018

    Report

    Report Number
    3004209178-2018-01603
    Event Type
    Injury
    Date Received
    January 29, 2018
    Date of Event
    November 29, 2017
    Report Date
    March 26, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT IT WAS NOTED THAT THE PATIENT HAD 2 IMPLANTABLE NEUROSTIMULATORS (INS) PRESENT DURING THE EVENT. SEE MANUFACTURER¿S REPORT # 3004209 178-2018-01602 FOR THE CONCOMITANT INS INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATED THE PATIENT'S SYMPTOMS WERE A RESULT OF THE INS BEING DEPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER STATING THEIR HEALTHCARE PROFESSIONAL HAD BEEN NOTIFIED AND THEY HAD AN APPOINTMENT (B)(6) 2017. THE CAUSE OF THE TINGLING/TREMOR NOT BEING SUPPRESSED AND THE PATIENT PROGRAMMER NOT TURNING ON WAS NOT DETERMINED. IT WAS REPORTED THE LEFT AND RIGHT STIMULATORS WERE REPLACED (B)(6) 2018. THE PATIENT REPORTED THE TINGLING/TREMOR ISSUE AND PATIENT PROGRAMMER ISSUE HAD BEEN RESOLVED "SO FAR".

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR. IT WAS REPORTED THAT WHEN THE PATIENT WOKE UP, BRUSHED THEIR TEETH, AND ATE BREAKFAST, THEIR TREMOR WAS NOT SUPPRESSED. THE PATIENT STATED THAT A ¿TINGLE CAME DOWN¿ THEIR ARM AND THEY WERE NOT SURE IF THEY TRIGGERED IT OR DID NOT GIVE IT ¿ENOUGH OF A CHANCE AFTER CHANGING SETTINGS¿. IT WAS ALSO NOTED THAT WHEN DRIVING DOWN THE DRIVEWAY, THEY FELT A TINGLING. THE DATES OF THESE OCCURRENCES WERE UNKNOWN AND THEY NOTED IT WAS A RANDOM OCCURRENCE. THE PATIENT STATED THAT IT HAD NOT BEEN A PROBLEM BUT THEY THOUGHT ¿MAYBE A LOOSE WIRE OR SOMETHING¿. IT WAS ALSO REPORTED THAT THE PATIENT HAD SEVERAL OCCURRENCES WHERE THE PROGRAMMER DID NOT TURN ON. AS PART OF TROUBLESHOOTING, THE BATTERIES WERE CHANGED AND THE UNIT WORKED (THE PATIENT CHECKED THE OLD BATTERIES AND THEY WERE GOOD. A FEW DAYS LATER, THE ISSUE OCCURRED AGAIN WHERE THE PROGRAMMER WOULD NOT START UP. AGAIN, THEY JUST TOOK THE BATTERIES OUT AND PUT THEM BACK IN AND THE UNIT STARTED WORKING AGAIN. THE PATIENT DID MENTION THAT ONE OTHER TIME, THE UNIT GAVE THEM A ¿SYMBOL OR ICON¿ BUT THEY DID NOT WHAT THAT WAS. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69797 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention