BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 20599826 · Received November 4, 2024

    Report

    Report Number
    3004209178-2024-21450
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    January 21, 2021
    Report Date
    November 14, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    UDI-DI
    00763000253363
    PMA / PMN Number
    H020007
    Removal / Correction Number
    Z-2427-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ACTIVA; PRODUCT ID A610 (LOT: UNKNOWN); PRODUCT TYPE: 0216-SOFTWARE 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.

    Additional Manufacturer Narrative · 0

    SECTION D10 REFERENCES: PRODUCT ID A610 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE SOFTWARE 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

    MDT REP REPORTED THAT SINCE IMPLANT OF PERCEPT PC, THE ADAPTOR WAS NOT LISTED IN THE COMPONENTS FEATURE. IT IS UNCLEAR IF THIS WAS RELATED TO THE TRANSFER OF SETTINGS FROM THE ACTIVA PC TO THE PERCEPT PC. NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED TO RESOLVE THE ISSUE THE REP HAD TO SET UP THE COMPONENTS THE CORRECT WAY WITH AN ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631103 PERCEPT IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M MRU MEDTRONIC PUERTO RICO OPERATIONS CO. B35200 00763000253363

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male SEE H11| SEE H11...