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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENVOY MEDICAL ESTEEM
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ENVOY MEDICAL ESTEEM Back to Search Results
Model Number 2001
Device Problems Electrical /Electronic Property Problem (1198); Low impedance (2285); Impedance Problem (2950)
Patient Problem Hearing Impairment (1881)
Event Date 05/19/2014
Event Type  malfunction  
Event Description
On (b)(6) 2012.Pt was implanted (right ear) by dr.(b)(6).On (b)(6) 2013 fitting: "there was also a peak in the fb test at -45db at 1500hz." on (b)(6) 2014 fitting: programming out of fb not possible.On (b)(6) 2014 transfer of care: patient has been referred to (b)(6).Release was received and medical records sent to (b)(6).On (b)(6) 2014 envoy becomes aware that a revision surgery has been scheduled.On (b)(6) 2014 revision surgery.On (b)(6) 2014 envoy receives the device and begins analysis.
 
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Brand Name
ESTEEM
Manufacturer (Section D)
ENVOY MEDICAL
saint paul MN
Manufacturer Contact
tim kappers
5000 township parkway
saint paul, MN 55110
6513618000
MDR Report Key3964405
MDR Text Key4626644
Report Number3004007782-2014-00013
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 06/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/16/2012
Device Model Number2001
Device Lot NumberEMC0004477
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/12/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2011
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 Age92 YR
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