BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7609165 · Received June 18, 2018

    Report

    Report Number
    3004209178-2018-13601
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID (B)(4) LOT# V875361 SERIAL# IMPLANTED: (B)(6) 2012 EXPLANTED: PRODUCT TYPE LEAD: DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT.IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40 LOT/SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD, UBD: 26-AUG-2014, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE CAUSE OF THE IMPEDANCES WERE UNKNOWN. IT WAS THOUGHT THAT THE NEUROLOGIST THOUGHT EXTRA TROUBLESHOOTING WAS DONE TO HELP RESOLVE THE ISSUE, BUT IT DIDN'T WORK. THE ISSUE WAS NOT RESOLVED AT THAT TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL AND CONSUMER VIA THE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT HAD A LACK OF TREMOR CONTROL. NO KNOWN FACTORS WERE THOUGHT TO HAVE LED OR CONTRIBUTED TO THE ISSUE. IMPEDANCE CHECK ON (B)(6) 2018 SHOWED ALL COMBINATIONS INCLUDING ELECTRODES 1 AND 3 WERE OUT OF RANGE WITH HIGH IMPEDANCES. NO INTERVENTION WAS PERFORMED AND NO SURGERY WAS PLANNED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THE PATIENT REPORTED THEY THOUGHT THERE HAD ALWAYS BEEN HIGH IMPEDANCES. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454685 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1