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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENVOY MEDICAL CORPORATION ESTEEM; ESTEEM II, PRODUCT CODE: OAF
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ENVOY MEDICAL CORPORATION ESTEEM; ESTEEM II, PRODUCT CODE: OAF Back to Search Results
Model Number 2001
Device Problem Electrical Shorting (2926)
Patient Problem Hearing Impairment (1881)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
Patient is experiencing feedback that is consistent with electrical feedback, not mechanical feedback, after a battery change.An abnormal sensor dx result was documented, with feedback scan and max gain of 10/10 were all noted.The patient reported a low frequency feedback.Esteem diagnostics showed potential issue with the sensor (frequency measured at 250 hz and 500 hz were not the same as the stimulus).There was also a significantly abnormal feedback scan and max gain dropped from 30/30 to 10/10.The device is demonstrating feedback similarly to other confirmed cases of electrical feedback and there is no reason to believe that feed back is mechanical in nature.The device failed to accurately measure two of four frequencies of test tones.Based on available test and diagnostic data, the source of the feed back cannot be conclusively identified, however the data reasonably suggests that a reportable event has occurred, requiring revision.Patient has not yet been seen to evaluate the issue medically, however the available test data reasonably suggests that a revision will be required.
 
Event Description
Envoy medical corp.(emc) was notified on (b)(6) 2019 a patient experiencing low frequency feed back after a battery change.Testing showed abnormal sensor diagnostics.Test results are consistent with electrical feedback, not mechanical feedback.Patient/clinical history with emc: (b)(6).
 
Event Description
Envoy medical corp.(emc) was notified on 02/08/19 a patient experiencing low frequency feed back after a battery change.Testing showed abnormal sensor diagnostics.Test results are consistent with electrical feedback, not mechanical feedback.-- update -- during the (b)(6) 2019 revision procedure, it was found that the sp header dip coat/insulation layer was damaged, likely by surgical instruments during the (b)(6) 2019 battery change procedure.Fluid ingress, attributed to the damaged dip coat, was found inside the header, likely causing the electrical feedback (electrical feedback due to fluid ingress has been documented in similar situations where header dip coat is damaged, i.E.Header abrasion, etc.).No transducer defects/issues were identified as was originally believed and reported in mdr 3004007782-2019-00001.This report shall serve as an update/follow up to mdr 3004007782-2019-00001.Patient/clinical history with emc: (b)(6) 2013 - implant (b)(6) 2013 - activation (b)(6) 2014 - fitting (b)(6) 2014 - fitting (b)(6) 2017 - fitting (b)(6) 2019 - battery change (b)(6) 2019 - diagnostics (b)(6) (b)(6) 2019 - case review completed (b)(6) 2019 - revision surgery.
 
Manufacturer Narrative
Patient is experiencing feedback that is consistent with electrical feedback, not mechanical feedback, after a battery change.An abnormal sensor dx result was documented, with feedback scan and max gain of 10/10 were all noted.The patient reported a low frequency feedback.Esteem diagnostics showed potential issue with the sensor (frequency measured at 250 hz and 500 hz were not the same as the stimulus).There was also a significantly abnormal feedback scan and max gain dropped from 30/30 to 10/10.The device is demonstrating feedback similar to other confirmed cases of electrical feedback and there is no reason to believe that feed back is mechanical in nature.-the device failed to accurately measure two of four frequencies of test tones.Based on available test and diagnostic data, the source of the feed back cannot be conclusively identified, however the data reasonably suggests that a reportable event has occurred, requiring revision.Patient has not yet been seen to evaluate the issue medically, however the available test data reasonably suggests that a revision will be required.-- update/follow-up -- mdr 3004007782-2019-00001.During the (b)(6) 2019 revision, it was found that the sp header dip coat/insulation layer was damaged, likely during the preceding battery change procedure, (b)(6) 2019.Fluid ingress was found in the header region, likely as a result of the insulative layer being broken.It is believed that the reported electrical feedback was caused by this fluid ingress and other damage to the device.Similar cases of header fluid ingress have been connected to similar electrical feedback (i.E.Header abrasion, etc.).The transucers (specifically the sensor) were not found to be defective, as previously believed.With the new information received and available testing performed, it is believed that the cause for the low frequency electrical feedback was fluid ingress caused by damage to the header dip coat/insulative layer.[3004007782-2019-00001-follow-up (1), (b)(4) - returned product evaluation summary.Pdf].
 
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Brand Name
ESTEEM
Type of Device
ESTEEM II, PRODUCT CODE: OAF
Manufacturer (Section D)
ENVOY MEDICAL CORPORATION
4875 white bear parkway
white bear lake MN 55110
MDR Report Key8404939
MDR Text Key139992637
Report Number3004007782-2019-00001
Device Sequence Number1
Product Code OAF
Combination Product (y/n)N
PMA/PMN Number
P090018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Notification
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/31/2019
Device Model Number2001
Device Catalogue Number902001-003
Device Lot NumberEMC0006290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/08/2019
Supplement Dates Manufacturer Received11/08/2019
Supplement Dates FDA Received12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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