BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7593267 · Received June 12, 2018

    Report

    Report Number
    3004209178-2018-13243
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    November 21, 2015
    Report Date
    August 22, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. DATE OF EVENT UPDATED. 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

    (B)(6) 2018: CRTS 3720884 , RPL 210249 (CON): 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 THE PATIENT CONSULTED WITH THE HEALTH CARE PROFESSIONAL (HCP) AND WAS TOLD TO ORDER STICKY PADS. IT WAS ALSO RE PORTED THAT PATIENT HAD TO CHARGE THE INS EVERY DAY AND THE STICKERS GET IRRITATED AND UNCOMFORTABLE TO PEEL OFF, EVERY DAY ON THE SAME EXACT SPOT, SO THE PATIENT WOULD LIKE TO GET THE BELT SO THEY CAN CHANGE UP HOW THEY CHARGE EVERY DAY. THE PATIENT WANTED TO REASSURE THAT IT WAS NOT RASHY OR ANYTHING , JUST UNCOMFORTABLE TO PEEL OFF EVERY DAY. AN EMAIL WAS SENT OUT ORDERING FOR A RECHARGE BELT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT. (B)(6) 2018 PATLTR (CON): ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT INDICATING THAT THE MANAGING PHYSICIAN IS AWARE OF THE PROBLEM. THEY HAVE DONE IT SINCE INSTALLED. 1/2 TO 3/4 HRS. IF DONE EVERYDAY WITH A FULL BAR DISPLAYED 1 HR. 15 MINUTES MINIMUM IF THEY MISS A DAY WITH A FULL BAR. THE CAUSE OF HAVING TO CHARGE EVERY DAY WAS DUE TO HIGH POWER SETTINGS. THEY MAY HAVE STARTED BECAUSE IT IS EASIER FOR THEM TO REMEMBER. NO ACTIONS/INTERVENTIONS WERE TAKEN. THE ISSUE IS NOT YET RESOLVED THEY STILL HAVE TO CHARGE EVERYDAY.

    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. IT WAS REPORTED THAT THE PATIENT CONSULTED WITH THE HEALTH CARE PROFESSIONAL (HCP) AND WAS TOLD TO ORDER STICKY PADS. IT WAS ALSO REPORTED THAT PATIENT HAD TO CHARGE THE INS EVERY DAY AND THE STICKERS GET IRRITATED AND UNCOMFORTABLE TO PEEL OFF, EVERY DAY ON THE SAME EXACT SPOT, SO THE PATIENT WOULD LIKE TO GET THE BELT SO THEY CAN CHANGE UP HOW THEY CHARGE EVERY DAY. THE PATIENT WANTED TO REASSURE THAT IT WAS NOT RASHY OR ANYTHING , JUST UNCOMFORTABLE TO PEEL OFF EVERY DAY. AN EMAIL WAS SENT OUT ORDERING FOR A RECHARGE BELT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435394 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR