BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HRES 90K

    MDR report key: 2061022 · Received April 4, 2011

    Report

    Report Number
    2061022
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    January 21, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD COCHLEAR IMPLANTATION ~3 YEARS (B)(6) AGO WITH IMPROVED HEARING. PATIENT WITH COMPLAINTS OF PERSISTENT PAIN OVER THE IMPLANT SITE. A WORKUP WAS COMPLETED WITH UNREMARKABLE FINDINGS. THERE WAS NO EVIDENCE OF INFECTION, OSTEOMYLITIS OR ANYTHING THAT COULD BE CAUSING THE PAIN OTHER THAN NEURALGIA. MEDICATION TREATMENT WAS UNSUCCESSFUL WITH PAIN RELIEF AND THE PATIENT REQUESTED REMOVAL OF IMPLANTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION CI-1400-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR