BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 21885246 · Received April 22, 2025

    Report

    Report Number
    2182207-2025-01085
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    February 22, 2025
    Report Date
    April 22, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 8637 LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE PUMP PRODUCT ID 8637 LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE PUMP SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8637, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 8637, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: CITATION: COSTICI, P. F. ET AL. SAFETY AND EFFICACY OF THE NOVEL SUBFASCIAL WITH UMBILICUS DETACHMENT TECHNIQUE FOR INTRATHECAL BACLOFEN THERAPY IN PEDIATRIC PATIENTS WITH CEREBRAL PALSY AND LOW BODY MASS INDEX. CHILD¿S NERV. SYST. 41, 118 (2025). DOI: 10.1007/S00381-025-06772-X 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

    LITERATURE WAS REVIEWED REGARDING 'SAFETY AND EFFICACY OF THE NOVEL SUBFASCIAL WITH UMBILICUS DETACHMENT TECHNIQUE FOR INTRATHECAL BACLOFEN THERAPY IN PEDIATRIC PATIENTS WITH CEREBRAL PALSY AND LOW BODY MASS INDEX'. THE FOLLOWING MEDTRONIC DEVICES WERE USED: SYNCHROMED PUMP. AMONG PATIENTS' ADVERSE EVENTS/DEVICE PERFORMANCE ISSUES INCLUDED: PATIENTS IMPLANTED WITH A PUMP USING THE SUBCUTANEOUS METHOD EXPERIENCED 2 CASES OF INFECTION, 4 CASES OF SKIN EROSION, 6 PUMP REVISIONS, AND 4 PUMP REMOVALS. PATIENTS IMPLANTED WITH A PUMP USING THE SUBFASCIAL METHOD EXPERIENCED 4 CASES OF INFECTION, 1 CASE OF SKIN EROSION, AND 1 PUMP REMOVAL. PATIENTS IMPLANTED WITH A PUMP USING THE NOVEL SUBFASCIAL WITH UMBILICUS DETACHMENT METHOD EXPERIENCED 1 CASE OF INFECTION RESOLVED WITH SURGICAL WASHING AND ANTIBIOTIC THERAPY. EXPERIENCED AN INFECTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258049 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

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