FDA.reportPublic FDA data

MAUDE MDR 7176880

MDR report key
7176880
Report number
3004007782-2015-00018
Event key
0
Event type
3
Date of event
2015-09-25
Date received
2018-01-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. TODD KOEPPEL
Address
5000 TOWNSHIP PARKWAY ST. PAUL MN 55110 US
Phone
651-651-6513
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ESTEEMESTEEM II SPENVOY MEDICAL CORP.OAF2001902001-003EMC0005337Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-0901. R

Event Narratives#

N

Patient 1

SUBMISSIONS TO THE HTTPS://ESGTEST.FDA.GOV/ ENVIRONMENT WERE CONDUCTED IN GOOD FAITH THAT ENVOY MEDICAL WAS FOLLOWING ALL MDR SUBMISSION REQUIREMENTS PER THE 21CFR803 REGULATION. THE ISSUE IS UNDER CORRECTIVE ACTION INVESTIGATION AND THIS SUBMISSION IS PART OF THE CONTAINMENT ACTIVITY FOR THAT ISSUE.

D

Patient 1

POST-AURICULAR SKIN BREAKDOWN. AT THE TIME OF THE PROCEDURE, THE PATIENT'S LEADS AND HEADER WERE VISIBLE. THE LIKELY REASON FOR THE ISSUE WAS AN ANTERIOR SP AND THE PATIENT'S USE OF EYE GLASSES, RESULTING IN EXCESSIVE SKIN TENSION. REVISION SURGERY WAS PERFORMED TO REPAIR WOUND. HISTORY: (B)(6) 2006 - INITIAL IMPLANT; (B)(6) 2006 - FOLLOW UP VISIT - NO ISSUES; (B)(6) 2009 - BATTERY REPLACEMENT - NO ISSUES; (B)(6) 2014 - BATTERY REPLACEMENT - NO ISSUES; (B)(6) 2014 - FITTING - NO INDICATION OF WOUND IN REPORTS, NO ISSUES; (B)(6) 2015 - REVISION SURGERY TO REPAIR WOUND. SP WAS REPLACED AT THIS TIME.