BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM

    MDR report key: 5768008 · Received July 4, 2016

    Report

    Report Number
    6000034-2016-01217
    Event Type
    Injury
    Date Received
    July 4, 2016
    Report Date
    August 25, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. CORRECTION: PER THE CLINIC, IT WAS REPORTED THAT THE DEVICE WAS REJECTED AT SURGERY; AND NOT EXPLANTED AS PREVIOUSLY REPORTED. THE CORRECT MODEL # IS CI24RE (L24); AND NOT CI42RE (CA) AS PREVIOUSLY REPORTED. THE CORRECT SERIAL # IS (B)(6); AND NOT (B)(4) AS PREVIOUSLY REPORTED. THE CORRECT PMA/510(K) IS, P130016; AND NOT P970051 AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JULY 5, 2016, BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818. EXEMPTION NUMBER E2016011. H3 OTHER TEXT : DEVICE NOT RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422168 NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM PGQ PGQ COCHLEAR LTD CI42RE (L24) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention