BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 18636296 · Received February 2, 2024

    Report

    Report Number
    3004209178-2024-03430
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    May 22, 2023
    Report Date
    February 2, 2024
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934611
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 37751 LOT# SERIAL# (B)(6) IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37751, SERIAL/LOT #: NKU426106N, UBD: , UDI#: 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

    IT WAS REPORTED THAT THE PATIENT'S RECHARGER WON'T TURN ON. THE CALLER CONFIRMED THAT THERE WAS NO PHYSICAL DAMAGE TO THE DESKTOP CHARGER AND THE GREEN LIGHT WAS ON. PSS HAD THE CALLER RESTART THE RECHARGER , THE TROUBLE SHOOTING STEPS THAT WERE TAKEN DID NOT RESOLVE PROBLEM. THE PATIENT CONFIRMED THAT THE PATIENT HAS A SECOND RECHARGER AND CAN STILL CHARGE THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REP STATED THAT THE PATIENTS SETTINGS ARE SO HIGH IT TAKES THE PATIENT 45 MINUTES TO CHARGE. PSS REVIEWED THE PROCESS TO TRANSITING THE PATIENT TO THE WIRELESS RECHARGER (WR) , AND SENT AN EMAIL TO THE LOCAL MANUFACTURER'S REPRESENTATIVES TO START THE PROCESS OF GETTING THE PATIENT THE WR. THE CALLER REQUESTED 2 WR DUE TO THE PATIENT HAVING 2 INSS. PSS ATTEMPTED TO CALL THE PATIENT REP BACK TO PROVIDE THE SECOND SERIAL NUMBER OF THE RECHARGER, BUT THE CALLER WAS NOT WITH THE DEVICE. THE CALLER STATED THEY WILL CALL PS BACK TOMORROW TO PROVIDE SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347568 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612 00613994934611

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male "SEE H10...."