BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 21737256 · Received April 1, 2025

    Report

    Report Number
    3004209178-2025-05590
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    July 1, 2024
    Report Date
    April 1, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000634094
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING DILAUDID VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS MALIGNANT PAIN. THE PATIENT REPORTED THAT IN JULY THEY HAD TO DO A PUMP REVISION BECAUSE WHEN THE PATIENT WAS STANDING UP IN CHURCH, THEY HEARD A LOUD POP AND THE PUMP HAD GOTTEN STUCK ON THE PEW AND WAS SIDEWAYS STICKING OUT OF HER STOMACH LIKE A TABLE. THE MANAGING PHYSICIAN DID AN EMERGENCY REVISION AND SINCE THE REVISION IT FEELS LIKE THE PUMP IS STILL MOVING A BIT INSIDE THE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166392 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000634094

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention