BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2617761 · Received June 15, 2012

    Report

    Report Number
    3007566237-2012-01367
    Event Type
    Injury
    Date Received
    June 15, 2012
    Date of Event
    June 30, 2011
    Report Date
    May 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE THE ARTICLE WAS PUBLISHED ONLINE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LI, D., CUI, Q., LIU, Y., WANG, X., LIU, C., LIU, S., ZENG, Y. CHEMOTHERAPY RESPONSE ANALYSIS FOR OSTEOSARCOMA WITH INTRA-ARTERIAL CHEMOTHERAPY BY SUBCUTANEOUS IMPLANTABLE DELIVERY SYSTEM. SPRINGER. 2011. 17:947-953. TO SUMMARIZE THE EXPERIENCE IN INTRA-ARTERIAL NEOADJUVANT CHEMOTHERAPY FOR EXTREMITY OSTEOSARCOMA. BETWEEN (B)(6) 2002 AND (B)(6) 2007,111 PATIENTS WITH STAGE IIB EXTREMITY OSTEOSARCOMA RECEIVED PREOPERATIVE INTRA-ARTERIAL THERAPY WITH SUBCUTANEOUS IMPLANTATION OF CHEMOTHERAPY PUMP AS WELL AS EN BLOC RESECTION, AND POSTOPERATIVE ADJUVANT CHEMOTHERAPY. THERE WERE 63 MALES AND 48 FEMALES WITH AN AVERAGE AGE OF 18 (RANGE, 14~39 YEARS). THE TIME FROM SYMPTOM ONSET TO HOSPITALIZATION VARIED FROM SEVERAL DAYS TO 6 MONTHS. THE INDUCTION CHEMOTHERAPY REGIMEN INCLUDES: EPIRUBICIN [50~70 MG/M2 BY 4-HOUR INTRA-ARTERIAL INFUSION/DAY FOR 3 DAY] AND CISPLATIN [100~120 MG/M2 BY 2-HOUR INTRA-ARTERIAL INFUSION/DAY FOR 3 DAYS] REPETITIVELY EVERY 2~3 WEEKS. AMONG WHICH 24 CASES ONLY RECEIVED TWO CYCLES INDUCTION CHEMOTHERAPY WAS SET TO NONSTANDARD CHEMOTHERAPY GROUP AND 87 CASES RECEIVED THREE TO SIX CYCLES INDUCTION CHEMOTHERAPY SET TO (B)(6). THE NUMBER OF PREOPERATIVE CHEMOTHERAPY-CYCLES OF (B)(6) DEPENDS ON THE CLINICAL AND RADIOGRAPHIC EVALUATION OF CHEMOTHERAPY EFFICACY. MEDIAN FOLLOW-UP TIME WAS 28 (8~48) MONTHS. THE RATE OF LIMB PRESERVATION SURGERY WAS 89.53% (77/86) IN STANDARD CHEMOTHERAPY GROUP, AND WAS 37.5% (9/24) IN NONSTANDARD CHEMOTHERAPY GROUP. (B)(6) ANALYSIS SHOWED THAT THE 3-YEAR OVERALL SURVIVAL RATE AND DISEASE FREE SURVIVAL RATE OF ALL THE 111 CASES WERE 68.3% AND 65.9% RESPECTIVELY. THERE WERE SIGNIFICANT DIFFERENCES IN OVERALL SURVIVAL RATE (38.9%, 80.0%, P=0.000), DISEASE FREE SURVIVAL RATE (30.1%, 79.5%, P=0.000), DISTANT METASTASIS RATE (66.67%, 16.09%, P=0.0000) AND LOCAL RECURRENCE RATE (58.33%, 13.79%, P=0.0000) BETWEEN NONSTANDARD CHEMOTHERAPY GROUP AND STANDARD CHEMOTHERAPY GROUP. STANDARD INTRA-ARTERIAL NEO-ADJUVANT CHEMOTHERAPY WAS MORE EFFECTIVE THAN NONSTANDARD INTRAARTERIAL INDUCTION CHEMOTHERAPY TO STAGE IIB EXTREMITY OSTEOSARCOMA. REPORTED EVENTS: THERE WERE 105 CASES OF NAUSEA/VOMITING, 39 OF WHICH SUFFERED THE SYMPTOMS AT LEVEL 3-4 ON THE FIRST DAY. BONE MARROW DEPRESSION OCCURRED 6-8 DAYS AFTER THE CHEMOTHERAPY WITH THE MOST SERIOUS CASES APPEARING AT DAY 8. NEUTROPHILIC GRANULOCYTOPENIA OCCURRED IN 91 CASES, 9 OF WHICH WERE AT LEVEL 3-4. ANEMIA OCCURRED IN 52 CASES, 5 OF WHICH WERE GREATER THAN LEVEL 3. OTHER COMPLICATIONS INCLUDED LIVER FUNCTION DAMAGE (9.91%), ERYTHEMA (5.41 %), AND TRANSIENT BRACHIAL PLEXUS NERVE DAMAGE/INJURY (2.70%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER: MODEL UNK, LOT# UNK