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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES ULTRA IMPLANT; COCHLEAR IMPLANT
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ADVANCED BIONICS, LLC HIRES ULTRA IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1600-05
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling (2091); Dizziness (2194); Swelling/ Edema (4577)
Event Date 01/05/2021
Event Type  malfunction  
Event Description
The recipient is reportedly experiencing a displaced magnet following a mri.The recipient presenting with pain, swelling, and dizziness.Revision surgery will be scheduled.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient's device was explanted for unrelated reason please refer to mdr #3006556115-2020-01422.The recipient's pain, swelling, and dizziness resolved.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 ULTRA IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
MDR Report Key10968414
MDR Text Key220903568
Report Number3006556115-2020-01486
Device Sequence Number1
Product Code MCM
UDI-Device Identifier07630016844584
UDI-Public(01)07630016844584(11)180503(17)210430
Combination Product (y/n)N
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2021
Device Model NumberCI-1600-05
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
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