BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER

    MDR report key: 8282754 · Received January 28, 2019

    Report

    Report Number
    9612007-2019-00003
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    December 18, 2018
    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 · 0

    THE DEVICE HISTORY RECORDS REVIEW OF THE IP1P LOT 210626, SN (B)(4) DID NOT REVEAL ANY ANOMALY THAT COULD EXPLAIN THE REPORTED EVENT. THE BATCH WAS MANUFACTURED IN OCTOBER 2018. DEVICE IDENTIFIER IP1P: (B)(4). MANUFACTURING DATE: (B)(4). EXPIRATION DATE: (B)(4). RELEASED DATE: 26 OCT 2018. NO DEVICE IS AVAILABLE FOR INVESTIGATION, THE COMPLAINT IS UNVERIFIABLE AND PER THE HOSPITAL, THE ROOT CAUSE WAS LINKED TO THE PROBE LOCATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CLINICAL TRIALS ADMINISTRATOR REPORTED ON BEHALF OF THE CUSTOMER THAT INITIALLY, THE VALUE OF THE IP1P (KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER) WAS CORRECT BUT AFTER TWO (2) HOURS, THE VALUE WAS AT ZERO (0) ON (B)(6) 2018. AFTER CHECKING, THE PROBE, IT WAS REPORTED TO BE IN A HEMORRHAGIC AREA. THE PROBE WAS REPLACED WITH ANOTHER ONE (2ND PROBE) THAT WAS PLACED IN AN UNINJURED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74735 KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA 0210626

    Patients

    Seq Age Sex Outcome Treatment
    1