BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 19831497 · Received July 25, 2024

    Report

    Report Number
    2182207-2024-03258
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 18, 2018
    Report Date
    July 25, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME INDURA; PRODUCT ID 8709 (SERIAL: (B)(6)); PRODUCT TYPE: 0184-CATHETER; IMPLANT DATE (B)(6) 2005; EXPLANT DATE (B)(6) 2015; UDI: (B)(4); UBD: 2006-12-28. 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 PATIENT RECEIVING INTRATHECAL UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT ADDED THAT 6-7 YEARS AGO, SHE WENT TO HAVE AN UNRELATED SURGERY WHERE THE ABANDONED CATHETER WAS IN THE WAY. AFTER THAT UNRELATED SURGERY, THE PATIENT'S STOMACH STARTED SWELLING AND THE PATIENT WENT BACK TO THE DOCTOR RIGHT AWAY AND WAS TOLD THE CATHETER WAS LEAKING. THE DOCTOR DID ANOTHER QUICK SURGERY TO TIE THE CATHETER SO IT DIDN'T LEAK INSIDE THE PATIENT. WHEN ASKED ABOUT SPECIFIC DATES, FACILITY AND HCP INFO, THE PATIENT STATED THAT SHE DIDN'T REMEMBER AS SHE MOVED FROM THAT STATE TOO. THE PATIENT SAID SHE WAS NOT THE BEST HISTORIAN SO SHE COULDN'T HELP WITH THESE LONG-GONE EVENTS FOR ANY FUTURE MDT INQUIRIES EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200347 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention SEE H11...