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

Model Number AB-5100L

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Code Available (3191)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient reportedly experienced shocking sensations with device use.External equipment was exchanged; but the issue was not resolved.Revision surgery has been scheduled.

Manufacturer Narrative

The recipient's device was explanted.

Manufacturer Narrative

(b)(4).The external visual inspection revealed that the electrode was severed 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 some of the electrical tests performed.The device passed the electrical and mechanical tests performed.The reported complaint of non-auditory stimulation could not be verified during this analysis, which was limited in some respects due to the electrode lead being severed prior to receipt.The device passed the tests performed.This older device configuration is not currently manufactured.This is the final report.

Manufacturer Narrative

The recipient was reimplanted with another advanced bionics cochlear device.The external visual inspection revealed that the electrode was severed 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 all of the electrical and mechanical tests performed.The device passed the tests performed.This older device configuration is not currently manufactured.This is the final report.

• Brand Name: CLARION¿ 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: 5651040
• MDR Text Key: 45055927
• Report Number: 3006556115-2016-00193
• Device Sequence Number: 1
• Product Code: MCM
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2000
• Device Model Number: AB-5100L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/1998
• 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: 22 YR