MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA IMPLANT; COCHLEAR IMPLANT

Model Number CI-1600-05

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Ossification (1428)

Event Date 10/23/2019

Event Type  Injury  

Event Description

The recipient reportedly had partial insertion due to ossification of the cochlea.The recipient presented with sound quality issues.The recipient ceased device use.The recipient underwent repositioning surgery to reinsert the electrode array.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly underwent repositioning surgery to reinsert the electrode array on (b)(6) 2019.The recipient's activation went well.This is the final report.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 9298072
• MDR Text Key: 173450475
• Report Number: 3006556115-2019-00665
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016844584
• UDI-Public: (01)07630016844584(11)180312(17)210331
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Model Number: CI-1600-05
• 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 Manufactured: 03/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR