BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP802 STANDARD RECHARGEABLE BATTERY MODULE (CARBON)

    MDR report key: 9589367 · Received January 14, 2020

    Report

    Report Number
    6000034-2020-00107
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Report Date
    December 23, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 15, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT'S RECHARGEABLE BATTERY WAS CRACKED AT THE CHARGE CONNECTION AND ALLEGEDLY STARTED SMOKING WHILE CHARGING. THERE WAS NO ALLEGATION OF SERIOUS INJURY ASSOCIATED WITH THE EVENT AND REPLACEMENT EQUIPMENT WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49301 CP802 STANDARD RECHARGEABLE BATTERY MODULE (CARBON) NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CP802 ACC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention