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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENVOY MEDICAL CORP ESTEEM; ESTEEM II SP
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ENVOY MEDICAL CORP ESTEEM; ESTEEM II SP Back to Search Results
Model Number 2001
Device Problems Electrical /Electronic Property Problem (1198); Output below Specifications (3004)
Patient Problem Hearing Impairment (1881)
Event Date 05/26/2016
Event Type  malfunction  
Event Description
Patient reported sudden loss in volume and feedback limitations initially around (b)(6) 2014.Nonsurgical approaches were attempted, but were unsuccessful.It appears that the patient had not been seen since 2014.A case review done in 2014 showed a decrease in max gain and an abnormal feedback test.Patient did well in 2012 and 2013, but a significant change in performance was noted in 2014.
 
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Brand Name
ESTEEM
Type of Device
ESTEEM II SP
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 township, MN 55110
6513618057
MDR Report Key7123202
MDR Text Key95811874
Report Number3004007782-2016-00004
Device Sequence Number1
Product Code OAF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P090018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Remedial Action Replace
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/19/2013
Device Model Number2001
Device Catalogue Number902001-003
Device Lot NumberEMC0004661
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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