BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 10862416 · Received November 18, 2020

    Report

    Report Number
    2182207-2020-01296
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    August 10, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CREASY, J., NAPIER, K., REED, S., ZANI, S., WONG, T., KIM, C., WILDMAN-TOBRINER, B., STRICKLER, J., HSU D., URONIS, H., ALLEN, P., L IDSKY, M. IMPLEMENTATION OF A HEPATIC ARTERY INFUSION PROGRAM: INITIAL PATIENT SELECTION AND PERIOPERATIVE OUTCOMES OF CONCURRENT HEPATIC ARTERY INFUSION AND SYSTEMIC CHEMOTHERAPY FOR COLORECTAL LIVER METASTASES. ANNALS OF SURGICAL ONCOLOGY, 2020; E-PUB AHEAD OF PRINT. DOI:10.1245/S10434-020-08972-Y. 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, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8637, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8637, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8637, SERIAL/LOT #: UNKNOWN. PER FDA DRAFT GUIDANCE JULY 9 2013 THESE EVENTS ARE REPORTED ON ONE MDR DUE TO NO PATIENT IDENTIFIER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: CREASY, J., NAPIER, K., REED, S., ZANI, S., WONG, T., KIM, C., WILDMAN-TOBRINER, B., STRICKLER, J., HSU D., URONIS, H., ALLEN, P., L IDSKY, M. IMPLEMENTATION OF A HEPATIC ARTERY INFUSION PROGRAM: INITIAL PATIENT SELECTION AND PERIOPERATIVE OUTCOMES OF CONCURRENT HEPATIC ARTERY INFUSION AND SYSTEMIC CHEMOTHERAPY FOR COLORECTAL LIVER METASTASES. ANNALS OF SURGICAL ONCOLOGY, 2020; E-PUB AHEAD OF PRINT. DOI:10.1245/S10434-020-08972-Y. SUMMARY: THE STUDY ENROLLED PATIENTS WITH CRLM SELECTED FOR HAI AFTER MULTI-DISCIPLINARY REVIEW NOVEMBER 2018¿JANUARY 2020. DEMOGRAPHICS, PRIOR TREATMENT, AND PERIOPERATIVE OUTCOMES WERE ASSESSED. OBJECTIVE HEPATIC RESPONSE WAS CALCULATED ACCORDING TO RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) 1.1. REPORTED EVENTS: (PLI 10): ONE PATIENT EXPERIENCED A SURGICAL SITE/HAI PUMP POCKET INFECTION WHICH WAS MANAGED WITH READMISSION, INTRAVENOUS ANTIBIOTICS, AND LAPAROSCOPICALLY ASSISTED RELOCATION OF A NEW PUMP TO THE RIGHT ABDOMEN. THE PATIENT RESUMED HAI THERAPY AND PROCEEDED WITHOUT ADDITIONAL COMPLICATIONS. (PLI 20): ONE PATIENT REQUIRED SECONDARY CLOSURE OF A PARTIAL FASCIAL DEHISCENCE AFTER THE INDEX OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327475 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention