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

Model Number CI-1400-01

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Increased Sensitivity (2065)

Event Date 04/01/2016

Event Type  Injury  

Event Description

The recipient reportedly experienced pain and tenderness at the implant site with device use.The recipient was prescribed an oral anti-inflammatory for the sensitivity at the implant site.External equipment was exchanged, and the recipient does not experience pain with one type of external processor.The recipient continues to use the device.The recipient continues to be monitored.

Manufacturer Narrative

The recipient is reportedly doing well and does not experience pain with device use.The recipient's device remains implanted.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient is reportedly doing well and using the device.The reported pain at the implant site has resolved.This is the final report.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient was reportedly prescribed the oral anti-inflammatory in (b)(6) 2016, however, the company was not informed of the exact prescription date.The recipient is reportedly doing well and using the device.The reported pain at the implant site has resolved.This is the final report.

• Brand Name: HIRES 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: rachael perez ; 28515 westinghouse place; valencia, CA 91355 ; 6613627734
• MDR Report Key: 5632954
• MDR Text Key: 44448743
• Report Number: 3006556115-2016-00186
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2005
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2016; 08/24/2016; 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2003
• 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: 13 YR