BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7793592 · Received August 17, 2018

    Report

    Report Number
    3004209178-2018-18515
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    May 15, 2018
    Report Date
    September 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA THE MANUFACTURING REPRESENTATIVE (REP) INDICATING THAT THE PATIENT WAS SEEN BY THE HCP AS THE PATIENT WAS REPORTING WORSENING PARKINSON'S DISEASE MOTOR SYMPTOMS (SHUFFLING, TREMORS, AND SLOWED MOVEMENT) AND SEVERE HALLUCINATIONS. PROVIDER RAN IMPEDANCE CHECK AND OBSERVED ALL HIGH IMPEDANCES (OPEN CIRCUIT) FOR ALL COMBINATIONS. THE REP WAS CALLED TO RE-VERIFY AND THEY WERE STILL HIGH.THE REP PROVIDED THE INTRA-OP IMPEDANCES FROM THEIR REPLACEMENT SURGERY IN JUNE 2018 AND THOSE WERE ALL NORMAL. ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE INCLUDE BOTH THE PATIENT AND CAREGIVER REPORTING REPEATED, SEVERE FALLS OVER THE COURSE OF THE PAST MONTH OR SO AS A RESULT OF THE WORSENING OF THE PATIENT'S MOTOR SYMPTOMS. ACTIONS/INTERVENTIONS INCLUDED RESULTS BEING NOTED AND THE PATIENT HAS BEEN REFERRED BACK TO THE SURGEON FOR IMAGING AND EVALUATION. THE ISSUE IS NOT YET RESOLVED.

    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF PARKINSON¿S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THE CALLER READ THE BATTERY ON (B)(6) 2018 AND SAW ALL THE CONTACTS WERE OVER 40K. THE CALLER STATED THAT THE PATIENT WAS FINE SYMPTOMATICALLY BUT THEN INDICATED THAT IN THE 3 MONTHS PRIOR HE HAD EXPERIENCED A DECLINE IN MOBILITY, MORE FREEZING, AND COGNITIVE DYSFUNCTION. SHE ALSO REPORTED THAT THE PATIENT HAD HALLUCINATIONS BUT THEN STATED THOSE WERE FROM HIS MEDICATION. NO FALLS OR TRAUMA WERE REPORTED. THE PATIENT WAS ALSO NEW TO THIS CLINIC AND STATED THAT SHE WOULD LIKE TO FIND HER LOCAL MANUFACTURER REPRESENTATIVE. THE CALLER REPORTED THE PATIENT HAD RECENTLY HAD THE INS REPLACED BEFORE COMING TO SEE HER. SHE HAD BEEN UNABLE TO REACH THE PATIENT'S SURGEON. IT WAS REPORTED THE CALLER WAS NOT WITH THE PATIENT TO DO FURTHER TROUBLESHOOTING. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) VIA THE REP STATING AN X-RAY (SKULL SERIES AND A=P CHEST SERIES) WAS ORDERED BY THE HCP TO DETERMINE IF THERE WAS A BREAK IN THE LEAD. THE PHYSICIAN ASSUMED THE CAUSE WAS FROM REPEATED FALLS BY THE PATIENT. IT WAS REPORTED THE HIGH IMPEDANCES HAD NOT YET BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634567 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR