MAUDE Adverse Event Report: ADVANCED BIONICS ADVANCED BIONICS COCHLEAR IMPLANTS

Model Number CI-1500-04

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Complaint, Ill-Defined (2331)

Event Date 02/01/2017

Event Type  malfunction  

Event Description

Patient has bilateral advanced bionics cochlear implants and both internal case grounds have failed.Additionally, one of the implants was, per family report, causing shocking sensations to the patient.Those have now stopped after the external device grounds began to be used.

• Brand Name: ADVANCED BIONICS COCHLEAR IMPLANTS
• Type of Device: ADVANCED BIONICS COCHLEAR IMPLANTS
• Manufacturer (Section D): ADVANCED BIONICS ; valencia CA
• MDR Report Key: 6510724
• MDR Text Key: 73558190
• Report Number: MW5069228
• Device Sequence Number: 1
• Product Code: PGQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR