MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-05

Device Problem Defective Device (2588)

Patient Problem Swelling (2091)

Event Date 02/01/2019

Event Type  Injury  

Event Description

The recipient is reportedly experiencing poor retention.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The recipient's skin flap was surgically thinned on (b)(6) 2019.The recipient is presenting with post-op swelling and is being monitored.

Manufacturer Narrative

The recipient was able to achieve stable retention and is wearing the device consistently, however, it is believed that the recipient could benefit from a stronger magnet.The recipient is scheduled for a follow-up appointment in which a stronger magnet will be tried.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's post-operative swelling and scabbing reportedly resolved.The recipient's magnet strength was adjusted to a stronger magnet and adequate retention was achieved.This is the final report.

Manufacturer Narrative

The recipient is reportedly experiencing continued swelling and scabbing due to skin flap surgery, however, is still being monitored.

• Brand Name: HIRES¿ ULTRA 3D 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: 8331730
• MDR Text Key: 136477290
• Report Number: 3006556115-2019-00031
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)180906(17)210831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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: 67 YR