BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE DRUG INFUSION PUMP

    MDR report key: 22382222 · Received July 2, 2025

    Report

    Report Number
    3004209178-2025-11260
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    April 12, 2025
    Report Date
    July 2, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT TYPE PUMP SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: MARTENS, B.H.M.; ISKANDER, M.; SOUDANT, D.L.; VLES, G.F.; BONOUVRIÉ, L.A.; TEERNSTRA, O.P.M.; VLES, J.S.H.; VERMEULEN, R.J. EUROPEAN JOURNAL OF PAEDIATRIC NEUROLOGY. 2025. 56, 17¿23. FROM CHILDHOOD TO ADULTHOOD: LONG-TERM ASSESSMENT OF CONTINUOUS INTRATHECAL BACLOFEN THERAPY IN NON-AMBULANT SPASTIC CEREBRAL PALSY. DOI: 10.1016/J.EJPN.2025.04.002. 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 ¿FROM CHILDHOOD TO ADULTHOOD: LONG-TERM ASSESSMENT OF CONTINUOUS INTRATHECAL BACLOFEN THERAPY IN N ON-AMBULANT SPASTIC CEREBRAL PALSY.¿ AMONG PATIENTS' ADVERSE EVENTS/DEVICE PERFORMANCE ISSUES INCLUDED: 1. 1 PATIENT HAD BEEN SHORTLY ADMITTED TO A PSYCHIATRIC WARD DUE TO EXCESSIVE BACLOFEN RELEASE CAUSING A PSYCHOSIS. 2. 1 PATIENT HAD THE PUMP REMOVED DUE TO MENINGITIS. 3. 3 PATIENT'S HAD UNEXPECTED HOSPITAL ADMISSIONS THAT WERE DOSE OR REFILL-RELATED. 4. 1 PATIENT HAD AN UNEXPECTED HOSPITAL ADMISSION THAT WAS PUMP-RELATED. 5. 2 PATIENT'S EXPRESSED THAT REFILLS CAN BE A STRUGGLE DUE TO THE AMOUNT OF SPASTICITY MAKING IT DIFFICULT TO SIT STILL AND FIND THE MEMBRANE OF THE PUMP. 6. 2 PATIENT'S ENDURED DEPRESSION AND MOOD SWINGS AFTER PUMP IMPLANTATION. 7. SOME PATIENT¿S REPORTED A DETERIORATION IN GENERAL MOOD AND EMOTIONAL BEHAVIOR SINCE IMPLANT (FEELING ANXIOUS, FRUSTRATED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368325 IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Hospitalization| R "SEE H11...."