BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER

    MDR report key: 8282760 · Received January 28, 2019

    Report

    Report Number
    9612007-2019-00002
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    January 2, 2019
    Report Date
    January 9, 2019
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED PROBE AND INTRODUCER WERE THROWN AWAY AT THE HOSPITAL. THE DEVICE HISTORY RECORDS OF REF IP1P LOT 206252 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY THAT COULD EXPLAIN THE REPORTED EVENT. WITHOUT ACTUAL DEVICE TO ANALYZE, THE COMPLAINT IS UNVERIFIABLE AND ITS EXACT ROOT CAUSE COULD NOT BE DETERMINED. DEVICE IDENTIFIER IP1P (B)(4). MANUFACTURING DATE (11)180115. EXPIRATION DATE (17)190115.

    Description of Event or Problem · 1

    A CLINICAL TRIAL ADMINISTRATOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE IP1P (KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER) HAD A BROKEN OF EXTENSION TUBE WHEN ASSEMBLING TO THE INTRODUCER AFTER MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2019. DEVICE BROKE AT THE JOINT LEVEL. THE KIT WAS TAKEN OFF FOR THE MRI. THE PROBE WAS WORKING BEFORE DISCONNECTION. REPLACEMENT OF THE PROBE WITH ANOTHER ONE WAS REPORTED. THE DEVICE WAS NOT KEPT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74930 KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA 0206252

    Patients

    Seq Age Sex Outcome Treatment
    1