BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8321519 · Received February 8, 2019

    Report

    Report Number
    3004209178-2019-02746
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    September 13, 2018
    Report Date
    May 9, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864238
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389S-40, LOT# VA1TD6L, IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4), UBD: 03-APR-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389S-40, LOT# VA1TD6L, IMPLANTED: (B)(6) 2018. PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT PATIENT NEVER HAD THERAPEUTIC EFFECT AND WAS NOT RESPONDING TO THE PROGRAMMING THAT THE NEUROLOGIST WAS DOING. THE DOCTOR SUSPECTED THAT SOMETHING WAS WRONG AND INSISTED PATIENT SHOULD GO SEE THE SURGEON. THE SURGEON DID AN MRI ON (B)(6) 2018, PATIENT HAD AN APPOINTMENT WITH THE SURGEON AND THE MANUFACTURER'S REPRESENTATIVE (REP), THEY INFORMED THE PATIENT AT THAT APPOINTMENT THAT THE MRI SHOWED ONE LEAD HAD MIGRATED, IT IS NOT WHERE IT IS SUPPOSED TO BE. THE CALLER STATED THAT THERE WAS NO ISSUE WITH THE DEVICE, IT IS AN ISSUE WITH THE ACTUAL IMPLANT SURGERY/LEAD MIGRATED. PATIENT HAD NO FALLS/NO TRAUMA. THE REP CHANGED THE SETTINGS AT THE APPOINTMENT LAST WEDNESDAY. AT THE END OF THE APPOINTMENT THE SURGEON INSTRUCTED THE REP TO GET IN CONTACT WITH THE NEUROLOGIST TO UPDATE HIM WHAT NEW SETTINGS WERE AND SHARE WITH HIM THE MRI IMAGES. THE CALLER STATED THAT THEY LEARNED THAT THE REP HAD NOT CONTACTED THE HEALTH CARE PROFESSIONAL (HCP), CALLER HAD BEEN CALLING THE REP SINCE MONDAY ASKING THEM TO CONTACT THE NEUROLOGIST AND CALL THE PATIENT BACK, BUT HAS NOT HEARD BACK FROM THE REP. PATIENT'S APPOINTMENT WITH THE NEUROLOGIST IS ON FRIDAY. IT WAS NOTED THAT THE NEUROLOGIST SOMEHOW WAS ABLE TO OBTAIN THE INFO ABOUT THE NEW SETTINGS BUT NOT DIRECTLY FROM THE REP, AND THE CALLER WAS UPSET. IT WAS STATED THAT THE NEUROLOGIST CANNOT GET THE MRI RESULTS BECAUSE THAT FACILITY IS IN A DIFFERENT NETWORK, ONLY THE SURGEON AND THE PATIENT CAN HAVE ACCESS TO THAT. CALLER ALSO REPORTED THAT PATIENT HAD A VISION PROBLEM AFTER IMPLANTED WHICH THEY DID NOT HAVE BEFORE. AFTER THE REP DID REPROGRAMMING LAST WEDNESDAY , THE PATIENT'S VISION HAS ABSOLUTELY IMPROVED SINCE THEN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THAT AT THEIR APPOINTMENT ON (B)(6) 2019 WITH THE SURGEON, PATIENT WAS TOLD THAT NO ACTION WOULD BE TAKEN FOR THE MIGRATED LEAD, IT WILL JUST MAKE ONE OR MORE OF THE SENSORS UNUSABLE/INEFFECTIVE. PATIENT ALSO REPORTED THAT THUS FAR, THEY HAVE NOT HAD AN IMPROVEMENT OF ANY OF THE PARKINSON'S SYMPTOMS USING THE STIMULATOR, WHICH IS VERY DISHEARTENING AND DISAPPOINTING. HOWEVER PATIENT REMAINS SOMEWHAT HOPEFUL THAT THEIR LOCAL NEUROLOGIST WILL BE ABLE TO HELP THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113505 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169864238

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR