BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7768674 · Received August 9, 2018

    Report

    Report Number
    3004209178-2018-17828
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    February 8, 2018
    Report Date
    September 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER APPLICABLE COMPONENTS ARE : PRODUCT ID: 3708660, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2016 PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708660, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. 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 PATIENT INDICATING THAT IMPEDANCES WERE 5000 IN (B)(6) 2017, 10000 IN (B)(6) 2018 AND 17,000 ON (B)(6) 2018. THE CAUSE OF THE HIGH IMPEDANCE READINGS WAS NOT KNOWN BUT THE PATIENT'S PERSONAL SUSPICION WAS THAT THE CONNECTING WIRE WAS TOO SHORT. PATIENT ALSO MENTIONED THAT THE DOCTOR STATED THAT IT DID NOT MATTER AND WAS NOT CONCERNED, THEREFORE NO TREATMENT OR ACTION WAS TAKEN TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE OF THE EVENT (B)(6) 2018 IS AN ESTIMATE. 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. PATIENT REPORTED THAT THEY RECENTLY MET WITH THEIR DOCTOR AND THE PATIENT'S DEVICE WAS CHECKED FOR CONNECTIVITY. ONE READING WAS AT 17,000 WHEN THEY BELIEVE THAT IT SHOULD BE AROUND 2,000. PATIENT INDICATED THAT AS THIS WAS A REFLECTION OF THE QUALITY OF THEIR IMPLANT, THEY WERE A LITTLE CONCERNED ABOUT THE READING WHICH HAS BEEN SLOWLY CLIMBING FROM VISIT TO VISIT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATING THAT 6 MONTHS AGO THEY CHECKED THEIR DEVICE CONNECTIVITY AND IT WAS AT 5000. PATIENT WAS CONCERNED THAT THE CONNECTIVITY LEVEL WITH THE LEADS WAS AFFECTING THEIR THERAPY RESULTS. IT WAS SUGGESTED FOR PATIENT TO CONTINUE TO WORK WITH THE DOCTOR ABOUT THEIR CONCERNS, PATIENT STATED THAT THE DOCTOR WAS NOT EXCITED ABOUT IT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610450 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR