BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 24316414 · Received February 11, 2026

    Report

    Report Number
    2649622-2026-04032
    Event Type
    Injury
    Date Received
    February 11, 2026
    Report Date
    February 11, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    PJS
    UDI-DI
    00763000236830
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 3387-40 LOT# V001440, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2026, PRODUCT TYPE: LEAD. 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 HAS A LEAD THAT IS EXPOSED AT THE INCISION SITE, LATER STATING IT IS STILL IN THE BODY, BUT STATES IT IS EXPOSED TO AIR. TECH SERVICES REVIEWED MRI LABELING; HOWEVER, REP REQUESTED AN ENGINEER CONTACT THEM AS SOON AS POSSIBLE. REP STATES THE PHYSICIAN WANTS TO PULL THE WIRES AND CUT THEM, BUT THE PATIENT HAS AN MRI SCHEDULED TOMORROW. REP WAS UNSURE WHEN THIS BEGAN. REP STATED THE IMPEDANCES WERE NORMAL LAST TIME HE MET WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING ON 1/22/26, THE LEAD AND EXTENSION WERE EXPLANTED, AND A PLUG WAS PLACED IN THE IMPLANT. THE OPEN WOUND WAS CLOSED BUT THE PATIENT HAS TO WAIT 3 MONTHS TO GET IMPLANTED. REP CLARIFIES THAT THE CONNECTION POINT BETWEEN THE LEAD AND EXTENSION ON THE LEFT SIDE OF THE PATIENT'S HEAD BEHIND THE EAR IS THE LOCATION OF THE EROSION. THE DEVICES HAVE NOT MIGRATED FROM THEIR IMPLANTED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375494 ACTIVA Stimulator, electrical, implanted, for essential tremor PJS MEDTRONIC PUERTO RICO VILLALBA 3708660 00763000236830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention "SEE H11...."