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

Model Number CI-1500-04

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 09/16/2015

Event Type  Injury  

Event Description

The recipient reportedly experienced dehiscence at the implant site.The recipient underwent local cleaning and primary resuture, and was treated with cefuroxime every twelve hours for ten days, however, the treatment was unsuccessful.The recipient experienced device exposure and underwent a flap rotation.The recipient again presented with device exposure.The recipient's device was explanted.The recipient's infection has resolved.

Manufacturer Narrative

Additional information: outcomes attributed to adverse events and device available for evaluation? correction: date of event and relevant tests/lab data.The recipient reportedly underwent a flap rotation and repositioning surgery on (b)(6) 2015.The recipient was prescribed cephalexin for seven days, and cephalexin and clindamycin iv for twenty-one days.The recipient was hospitalized (b)(6) 2015.

Manufacturer Narrative

(b)(4).The external visual inspection revealed the electrode was severed along the electrode prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented one of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.This is the final report.

• 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: rachael perez ; 28515 westinghouse place; valencia, CA 91355 ; 6613627734
• MDR Report Key: 5792018
• MDR Text Key: 49490161
• Report Number: 3006556115-2016-00297
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 06/22/2016

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: 07/31/2017
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/09/2016; 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR