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

Model Number CI-1400-02H

Device Problem Electrical Shorting (2926)

Patient Problem No Code Available (3191)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient is reportedly experiencing shorted electrodes.Programming adjustments were attempted, however, the issue is not resolved.Revision surgery is scheduled.

Manufacturer Narrative

Additional information: explant date, device available for evaluation, and device manufacture date.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

The device passed the external visual inspection.System lock was verified.The device passed the electrical tests performed.This is an interim report.

Manufacturer Narrative

The device passed both the external visual and photographic imaging inspections.System lock was verified.The device passed all of the electrical and mechanical tests performed.The scanning electron microscopy analysis found parylene damage at some electrode contacts and electrodes.The reported complaint of electrode shorts could not be verified during this analysis.However, damage to the parylene wire coating was found on wires inside the array that are consistent with the electrode short locations reported.Although no electrode shorts were electrically verified, the damage could have caused shorts between these adjacent contacts while implanted in the patient's cochlea.A capa was implemented.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: 5957328
• MDR Text Key: 55259840
• Report Number: 3006556115-2016-00404
• Device Sequence Number: 1
• Product Code: MCM
• 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: Audiologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2006
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2006
• 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 Age: 74 YR