BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 10951445 · Received December 5, 2020

    Report

    Report Number
    2182207-2020-03031
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    August 21, 2020
    Report Date
    December 4, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DELHAAS E.M., VAN ASSEMA D.M.E., FRÖBERG A.C., ZWEZERIJNEN B.G.J.C., HARHANGI B.S., FRANKEMA S.P.G., HUYGEN F.J.P.M., VAN DER LUGT A. 2020. ISOTOPIC SCINTIGRAPHY IN INTRATHECAL DRUG DELIVERY FAILURE: A SINGLE-INSTITUTION CASE SERIES. NEUROMODULATION 2020; E-PUB AHEAD OF PRINT. DOI:10.1111/NER.13275 DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: DELHAAS E.M., VAN ASSEMA D.M.E., FRÖBERG A.C., ZWEZERIJNEN B.G.J.C., HARHANGI B.S., FRANKEMA S.P.G., HUYGEN F.J.P.M., VAN DER LUGT A. 2020. ISOTOPIC SCINTIGRAPHY IN INTRATHECAL DRUG DELIVERY FAILURE: A SINGLE-INSTITUTION CASE SERIES. NEUROMODULATION 2020; E-PUB AHEAD OF PRINT. DOI:10.1111/NER.13275 SUMMARY: RETROSPECTIVE ANALYSIS OF ROUTINELY COLLECTED OBSERVATIONAL DATA FROM A CASE SERIES OF PATIENTS IN THE SETTING OF THE ACADEMIC CENTER FOR PAIN MEDICINE, DEPARTMENTS OF RADIOLOGY AND NUCLEAR MEDICINE AND NEUROSURGERY. TWENTY SEVEN PATIENTS PARTICIPATED BETWEEN JANUARY 2014 AND JANUARY 2019. THIRTY-SIX OPTIMIZED EXAMINATIONS INCLUDING STANDARDIZED PUMP FLOW RATE WITH ADDITIONAL SPECT-CT IMAGING AND A STEPWISE STANDARDIZED ANALYSIS WERE PERFORMED. A 10 ML MIXTURE OF MEDICATION AND 20 MBQ 111IN-DTPA WAS INJECTED INTO THE PUMP RESERVOIR. PLANAR AND SPECT-CT IMAGES WERE ACQUIRED AT 24, 48, AND 72 HOURS (H) AFTER INJECTION AND AT 96 HOURS AND/OR SEVEN DAYS, IF NEEDED. ALL IMAGES WERE REASSESSED BY THE FIRST TWO AUTHORS USING AN OPTIMIZED PROCEDURE. REPORTED EVENTS: A 66 YEAR OLD MALE EXPERIENCED LEAKAGE VIA A RETAINED CATHETER. THEIR DOSE WAS ADJUSTED. A 64 YEAR OLD MALE EXPERIENCED A CEREBROSPINAL FLUID OBSTRUCTION. THE FLOW WAS RESTORED. A 47 YEAR OLD FEMALE EXPERIENCED A CEREBROSPINAL FLUID OBSTRUCTION. THE FLOW WAS RESTORED. A 38 YEAR OLD MALE EXPERIENCED A CEREBROSPINAL FLUID OBSTRUCTION. THE FLOW WAS RESTORED. A 46 YEAR OLD FEMALE EXPERIENCED A CEREBROSPINAL FLUID OBSTRUCTION. THE FLOW WAS RESTORED. A 37 YEAR OLD MALE EXPERIENCED A CEREBROSPINAL FLUID OBSTRUCTION. THE FLOW WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417735 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1