BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K¿ ADVANTAGE IMPLANT

    MDR report key: 13169108 · Received January 5, 2022

    Report

    Report Number
    3006556115-2021-02018
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    May 4, 2021
    Report Date
    December 15, 2021
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED CUTS IN THE SILICONE OVERMOLD ON THE TOP AND BOTTOM COVERS, AS WELL AS MISSING IE RING AND CUT IR RING MULTISTRAND WIRES. THESE ARE DUE TO THE DAMAGE THAT OCCURRED DURING REVISION SURGERY. PHOTOGRAPHIC INSPECTION CONFIRMED CUT IE RING MULTISTRAND WIRE. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. SYSTEM LOCK WAS VERIFIED. THE DEVICE PASSED THE ELECTRICAL AND MECHANICAL TEST PERFORMED. THIS DEVICE WAS EXPLANTED FOR MEDICAL REASONS. THE DEVICE PASSED THE TESTS PERFORMED. THIS IS THE FINAL REPORT. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED CUTS IN THE SILICONE OVERMOLD ON THE TOP AND BOTTOM COVERS, AS WELL AS MISSING A ELECTRODE GROUND RING AND CUT ELECTRODE GROUND RING MULTISTRAND WIRES. THESE ARE DUE TO THE DAMAGE THAT OCCURRED DURING REVISION SURGERY. THE PHOTOGRAPHIC IMAGING INSPECTION CONFIRMED CUT ELECTRODE GROUND RING MULTISTRAND WIRES. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. SYSTEM LOCK WAS VERIFIED. THE DEVICE PASSED THE ELECTRICAL AND MECHANICAL TEST PERFORMED. THIS DEVICE WAS EXPLANTED FOR MEDICAL REASONS. THE DEVICE PASSED THE TESTS PERFORMED. THIS IS THE FINAL REPORT. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Description of Event or Problem · 0

    THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION AND IRRITATION AROUND THE IMPLANT SITE. THE RECIPIENT'S DEVICE WAS EXPLANTED. DURING EXPLANT SURGERY, THE AREA WAS CLEANED. THE RECIPIENT WAS PRESCRIBED ANTIBIOTICS (TYPE UNKNOWN). THE RECIPIENT'S INFECTION RESOLVED. ON (B)(6) 2021, THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573059 HIRES 90K¿ ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Required Intervention