MAUDE Adverse Event Report: ENVOY MEDICAL CORP. ESTEEM; ESTEEM II SOUND PROCESSOR

Model Number 2001

Device Problems Electrical /Electronic Property Problem (1198); Low impedance (2285); Impedance Problem (2950)

Patient Problem Hearing Impairment (1881)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

It was implanted with the esteem system (b)(6) 2012.On (b)(6) 2014 pt was receiving a fitting, indicated onset of feedback approx 3 weeks earlier.On (b)(6) 2014 pt went in for a local anesthesia surgery which replaced the sound processor (sp).On (b)(6) 2014 the sound processor was received by envoy.Device is currently under investigation.Results to be included in report and forth-coming update.No pt injury other than revision surgery resulted.

Manufacturer Narrative

The device was sent to a test facility for additional testing to verify hermeticity and internal vapor content.On 04/21/2014 envoy medical received communication from the test facility reporting back that they had damaged the device and failed to collect the requested test data.Envoy has completed the device evaluation.

Event Description

It was reported that the customer received a power source alert after plugging the pump into a wall outlet.Customer¿s blood glucose value was 160 mg/dl.Reportedly, the alert cleared and the pump successfully began charging after leaving the pump plugged into the power source.

Manufacturer Narrative

The device was sent to a test facility for additional testing to verify hermeticity and internal vapor content.On 04/21/2014 envoy medical received communication from the test facility reporting back that they had damaged the device and failed to collect the requested test data.Envoy has completed the device evaluation.

Event Description

See 3004007782-2014-00005 for initial report.The device was sent to a test facility for additional testing to verify hermeticity and internal vapor content.On 04/21/2014 envoy medical received communication from the test facility reporting back that they had damaged the device and failed to collect the requested test data.Envoy has completed the device evaluation.

• Brand Name: ESTEEM
• Type of Device: ESTEEM II SOUND PROCESSOR
• Manufacturer (Section D): ENVOY MEDICAL CORP.; 4875 white bear parkway; white bear lake MN 55110
• Manufacturer Contact: todd koeppel ; 4875 white bear parkway; white bear lake, MN 55110 ; 6513618000
• MDR Report Key: 3855512
• MDR Text Key: 19408500
• Report Number: 3004007782-2014-00005
• Device Sequence Number: 1
• Product Code: OAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,company representative,hea
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2013
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0004661
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2012
• 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: 78 DA