BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 24837204 · Received April 9, 2026

    Report

    Report Number
    3004209178-2026-06239
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 18, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: TM90T0, SERIAL #: (B)(6) , UBD: 25-JAN-2025, UDI#: (B)(4)., PRODUCT TYPE: ACCESSORY 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE TO AN IMPLANTABLE PUMP INFUSING UNKNOWN DRUG FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT STATED THEIR COMMUNICATOR HAD A SHORT IN IT AND DIDN'T WANT TO CHARGE FOR ABOUT 4 DAYS. THE COMMUNICATOR CHARGING PORT WAS LOOSE AND THE PATIENT STATED THEY HAD SCOTCH TAPE MASKING TAPE AROUND THE BOTTOM TO TRY TO PULL IT INTO A CERTAIN POSITION WHERE THE LIGHT WOULD GO ON. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314811 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female SEE H11...