BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 19156578 · Received April 22, 2024

    Report

    Report Number
    3004209178-2024-09534
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Report Date
    April 22, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    UDI-DI
    00763000519223
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3389-40 LOT# SERIAL# (B)(6) IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT LOT# SERIAL# UNKNOWN IMPLANTED: 2003-06-12 EXPLANTED: PRODUCT TYPE EXTENSION SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389-40, SERIAL/LOT #: (B)(6), UBD: , UDI#: ; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE BATTERY CHECK WHEN IT WAS DISCOVERED THAT RIGHT CONTACT 1 HAD HIGH IMPEDANCE. THE CAUSE IS UNKNOWN. PATIENT DENIES ANY FALLS, REPORTS NO CHANGE IN THERAPY, AND NO ADVERSE SIDE EFFECTS. BATTERY AT 2.91V AND NO REPLACEMENT NEEDED AT THIS TIME. PATIENT DOES NOT WANT ANY CHANGES TO SETTINGS. NO FURTHER ACTION TAKEN OR NEEDED AT THIS TIME. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT IS UNKNOWN IF THE IMPEDANCE ISSUE IS WITH THE LEAD, EXTENSION, OR BATTERY. NO SURGICAL INTERVENTION IS BEING TAKEN AS THE PATIENT REPORTS RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081155 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00763000519223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female