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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-04
Device Problems Low impedance (2285); Output Problem (3005); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/04/2022
Event Type  Injury  
Event Description
The recipient reportedly experienced decreased performance and low impedances.The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient¿s device was reportedly lost and will not return to advanced bionics for analysis.A review of the device history record was completed and no anomalies were noted.The recipient's device activation went well.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
 
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Brand Name
HIRES 90K¿ ADVANTAGE IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
alexandra gonzalez
28515 westinghouse place
valencia, CA 91355
MDR Report Key14504935
MDR Text Key292695955
Report Number3006556115-2022-00797
Device Sequence Number1
Product Code MCM
UDI-Device Identifier07630016828638
UDI-Public(01)07630016828638(11)141111(17)170930
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/30/2017
Device Model NumberCI-1500-04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age14 YR
Patient SexMale
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