BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5352234 · Received January 7, 2016

    Report

    Report Number
    3007566237-2016-00116
    Event Type
    Injury
    Date Received
    January 7, 2016
    Report Date
    December 12, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    SAULINO, M.F., DEER, T.R., RAUCK, R., CARAWAY, D., KIM, P., WALLACE, M.S., HUANG, I.Z., MILIKIEN, D., VANHOVE, G.F., MCDOWELL, G.C. EFFECTIVENESS AND SAFETY OF INTRATHECAL ZICONOTIDE USE AS THE FIRST AGENT IN PUMP (10594). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 118 . SUMMARY: THE PATIENT REGISTRY OF INTRATHECAL ZICONOTIDE MANAGEMENT (PRIZM) EVALUATES THE EFFECTIVENESS, SAFETY, AND PATIENT REPORTED OUTCOMES ASSOCIATED WITH THE USE OF INTRATHECAL ZICONOTIDE IN CLINICAL PRACTICE SETTINGS. REPORTED EVENTS: ENROLLMENT HAS CLOSED AT 93 PATIENTS; DATA ARE AVAILABLE FOR THESE PATIENTS IN THIS INTERIM ANALYSIS. AMONG PATIENTS ACTIVE AT THE MONTH 6 ASSESSMENT (N=57), 78.9% (45) REMAINED ON MONOTHERAPY WITH INTRATHECAL ZICONOTIDE. FIFTY-ONE PATIENTS (54.8%) RECEIVED ZICONOTIDE AS THE FIRST AGENT IN PUMP (FIP+), WHEREAS 42 (45.2%) DID NOT (FIP-). MEAN (SD) BASELINE NPRS SCORES WERE 7.4 (1.9) AND 7.9 (1.6) IN FIP+ AND FIP- PATIENTS, RESPECTIVELY. MEAN (SEM) PERCENTAGE CHANGE IN NPRS SCORES AT MONTH 6 WERE -29.4% (5.5%) IN FIP+ (N=26) AND 6.4% (7.7%) IN FIP- (N=17) PATIENTS. WHEN RESPONSE WAS DEFINED AS A =2-UNIT DECREASE IN NPRS SCORE, A RESPONSE RATE OF 51.9% WAS OBSERVED AT MONTH 6 FOR FIP+ VERSUS A RESPONSE RATE OF 17.6% FOR FIP- PATIENTS; SIMILARLY, WHEN RESPONSE WAS DEFINED AS A =30% DECREASE IN NPRS SCORE, THE RESPONSE RATE AT MONTH 6 WAS LARGER IN FIP+ THAN IN FIP- PATIENTS (46.2% VS 5.9%, RESPECTIVELY). THE MOST COMMON ADVERSE EVENTS (AES; IN =10% OF PATIENTS OVERALL) WERE NAUSEA (19.6% VS 7.1%; FIP+ VS FIP- PATIENTS, RESPECTIVELY), CONFUSED STATE (9.8% VS 11.9%), AND DIZZINESS (13.7% VS 7.1%). THE MOST COMMON SERIOUS AES (IN =2% OF PATIENTS OVERALL) WERE MENTAL STATUS CHANGE (0% VS 4.8%; FIP+ VS FIP- PATIENTS, RESPECTIVELY) AND SUICIDAL IDEATION (3.9% VS 0%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10230 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other