BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 11999067 · Received June 15, 2021

    Report

    Report Number
    3004209178-2021-09383
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 19, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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 RECEIVED FROM THE CONSUMER REPORTED THE CIRCUMSTANCES THAT LED TO THE RANDOM ELECTRIC IMPULSE CHARGING AND IM PLANT DEPLETING FASTER WAS THEM ¿SYNCING A HEART PUMP WITH THEIR PHONE AT THE INITIAL OCCURRENCE. DURING THE NEXT 3 TO 4 DAYS THEY EXPERIENCED A RANDOM OCCURRENCE WITH NO SPECIFIC TRIGGERS NOTED.¿ THE CONSUMER MADE AN URGENT APPOINTMENT WITH THEIR HEALTHCARE PROVIDER (HCP) WHERE NO ¿IMPEDIMENT WAS EVIDENT.¿ THE HCP CONTACTED THE MANUFACTURER¿S REPRESENTATIVE (REP) WHO INDICATED THERE APPEARED TO BE AN ISSUE, BUT THEY WEREN¿T SURE OF THE CAUSE. SINCE THE VISIT THERE HAD BEEN NO ELECTRIC IMPULSES CHARGING, BUT THE IMPLANT WAS STILL DEPLETING FASTER THAN NORMAL, BUT HAD NOW APPEARED TO BE BACK TO NORMAL. THE CONSUMER CONTINUED TO MONITOR THE IMPULSE CHARGING AND ALSO HAD THE OPTION TO TURN OFF THE AFFECTED SIDE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING RANDOM ELECTRIC IMPULSE CHARGING THROUGH PATIENT'S HEAD AND BODY ON THE LEFT SIDE, TO THE PATIENT'S TOE. CALLER SAID ISSUE STARTED WHILE PATIENT WAS SETTING UP BLUETOOTH TO THE GARAGE HEAT PUMP. IMPEDANCE CHECK DIDN'T DETECT ANY ISSUE, EVEN WITH PALPATION AND DIFFERENT HEAD POSITIONS. WHEN PATIENT RECHARGED HIS BATTERY WAS MUCH LOWER THAN PREVIOUS DAYS WHEN PATIENT RECHARGE, THIS IS PER THE TABLET ON THE 12TH, ACCORDING TO THE PHYSICIAN. ALTHOUGH, THE BATTERY IS AT AROUND 50% TODAY, APPEARING TO NOT DRAIN AS DRASTIC COMPARED TO THE 12TH. IMPEDANCE CHECK SHOWED RIGHTVIM11 1174 OHMS10 10649 9308 77511<(>&<)>8 162311<(>&<)>9 162711 <(>&<)>10 130810<(>&<)>8 141110<(>&<)>9 12779<(>&<)>8 1069LEFT3 823 OHMS2 7431 7750 8333<(>&<)>0 13583<(>&<)>1 12243<(>&<)>2 9562 <(>&<)>0 12001<(>&<)>2 9641<(>&<)>0 1040 OHMSRIGHT PROGRAM 9- 10+ 8+LEFT PROGRAM 2+ 1-. THE PATIENT WAS GOING TO MONITOR WHEN HE HAS SURGES AND DOCUMENT, ESPECIALLY WHAT HEAD POSITION AND WHAT HE WAS DOING, TO SEE IF THERE IS A PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897953 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR