ESTEEM 2001 902001-002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-16 for ESTEEM 2001 902001-002 manufactured by Envoy Medical.

Event Text Entries

[97954333] Device evaluation summary: returned device sp sn (b)(4) was tested (b)(6) 2013 upon return to emc and passed all fft testing except for battery voltage reading of 2. 683 v, which would be low for a new device in manufacturing testing, but not depleted, and consistent with a device that had been implanted for 2. 6 years. In summary, this sp was replaced for battery depletion, but the battery was not actually depleted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[97954334] Envoy medical was notified of a sound processor replacement due to battery depletion. This particular sound processor was implanted for 2. 6 years, which is less than the expected worst case battery life for normal operation of 2. 8 years. However, returned device testing indicated that battery was not actually depleted and device passed functional testing. Clinical history: (b)(6) 2006 - original implant by dr. (b)(6), right ear, sp sn (b)(4). (b)(6) 2006 - activation. (b)(6) 2006 - 2 month. (b)(6) 2009 - battery change (sp sn (b)(4) implanted). (b)(6) 2010 - revision (sp (b)(4) implanted, (b)(4) explanted). (b)(6) 2013 - early battery change (sp (b)(4) implanted, sp (b)(4) explanted). (b)(6) 2016 - review of history shows that returned device sp sn (b)(4) was tested (b)(6) 2013 upon return to emc and passed all fft testing except for battery voltage reading of 2. 683 v. While this battery voltage would be considered low for a new production device, it is not below the "low battery" threshold of 2. 4 v. The battery is in summary, this sp was replaced for battery depletion, but the battery was not actually depleted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004007782-2015-00005
MDR Report Key7197729
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-01-16
Date of Report2016-10-12
Date of Event2013-06-14
Date Mfgr Received2013-07-01
Date Added to Maude2018-01-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TODD KOEPPEL
Manufacturer Street4875 WHITE BEAR PARKWAY
Manufacturer CityWHITE BEAR LAKE MN 55110
Manufacturer CountryUS
Manufacturer Postal55110
Manufacturer Phone6513618000
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameESTEEM
Generic NameESTEEM II SOUND PROCESSOR
Product CodeOAF
Date Received2018-01-16
Returned To Mfg2013-07-01
Model Number2001
Catalog Number902001-002
Lot NumberEMC0003623
Device Expiration Date2011-05-04
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerENVOY MEDICAL
Manufacturer Address4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-01-16

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