BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 20206435 · Received September 12, 2024

    Report

    Report Number
    2182207-2024-03861
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    September 10, 2024
    Report Date
    December 9, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    CONTINUATION OF D10: PRODUCT ID A610 LOT# SERIAL# UNKNOWN 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.

    Additional Manufacturer Narrative · 0

    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 REP COULDN'T TURN OFF THE PERCEPT PC USING THE PATIENT HANDSET, THOUGH INTERROGATION COULD BE ESTABLISHED WITH TWO DIFFERENT TABLETS. THEY ALSO TESTED TO KEEP THE CTM AWAY FROM THE TABLET AND JUST TO MAKE SURE THAT NO LONG TEL WAS USED, SO NO TEL-N. THE REP GOT THE COMMUNICATION INTERRUPTED MESSAGE (804 ERROR CODE). THE PATIENT HAD AN ACTIVA SC IMPLANTED LESS THAN 20CM AWAY FROM THE PERCEPT PC. THIS IS THE SECOND PERCEPT PC AND WITH THE PREVIOUS ON, IMPLANTED IN THE SAME POCKET, NO TELEMETRY ISSUE WAS NOTIFIED. THEY SUSPECTED THAT THE PROXIMITY TO THE ACTIVA SC MIGHT HAVE AFFECTED THE TELEMETRY. TO SOLVE THE PROBLEM THEY TURNED OFF CLOSE TELEMETRY OPTION AS OFF, AND ONCE THAT WAS DONE THEY COULD TURN OFF THE THERAPY USING LONG DISTANCE TELEMETRY. LOGS WOULD BE RETURNED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT WAS VERY SKINNY SO BOTH INSS WERE NOT 20 CM APART. THEY TRIED DIFFERENT THINGS AND EVENTUALLY MADE ADJUSTMENT ON TELEMETRY WITH THE TABLET ON THE PERCEPT INS. THE REP PRACTICED WITH THE PATIENT AND AT THAT TIME, IT SEEMED THAT THE ISSUE WAS RESOLVED. HOWEVER, THE PATIENT CONTACTED THE REP STATING THE PATIENT IS STILL EXPERIENCING PROBLEMS CONNECTING. AS THEY SWITCH OFF AND ON VERY OFTEN DAILY, THIS WAS REALLY BOTHERING FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575749 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...