ESTEEM
Report
- Report Number
- 3004007782-2019-00005
- Event Type
- Injury
- Date Received
- August 29, 2019
- Date of Event
- August 22, 2019
- Report Date
- July 2, 2020
- Manufacturer
- ENVOY MEDICAL CORPORATION
- Product Code
- OAF
- PMA / PMN Number
- P090018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DEVICE EVALUATION SUMMARY: TEST RESULTS FROM DEVICE MANUFACTURING AND DHR WERE REVIEWED. ALL COMPONENTS IN QUESTION PASSED ALL FUNCTIONAL TESTING IN PRODUCTION AND PASSED QUALITY INSPECTIONS. NO ANOMALIES ASSOCIATED WITH STERILIZATION OF PRODUCT. NO DEVICE FAILURES ARE ALLEGED.
DEVICE EVALUATION SUMMARY: TEST RESULTS FROM DEVICE MANUFACTURING AND DHR WERE REVIEWED. ALL COMPONENTS IN QUESTION PASSED ALL FUNCTIONAL TESTING IN PRODUCTION AND PASSED QUALITY INSPECTIONS. NO ANOMALIES ASSOCIATED WITH STERILIZATION OF PRODUCT. NO DEVICE FAILURES ARE ALLEGED.
ENVOY MEDICAL CORP. (EMC) WAS NOTIFIED ON 08/22/19 OF A PATIENT THAT EXPERIENCED PERIOPERATIVE, SURGICAL INCISION SITE INFECTION, POST BATTERY CHANGE. PATIENT WAS TREATED BY PATIENT'S LOCAL ENT WITH A COURSE OF ANTIBIOTICS AND THE INFECTION WAS CLEARED. NO DEVICE DEFICIENCIES ARE ALLEGED. PATIENT/CLINICAL HISTORY WITH EMC: 130604 - IMPLANT, 130807 - ACTIVATION, 131030 - FITTING, 140122 - FITTING, 140430 - FITTING, 140917 - FITTING, 160928 - FITTING AND REMOTE SUPPORT, 190719 - BATTERY CHANGE, 190822 - EMC NOTIFIED OF SURGICAL INCISION SITE INFECTION (MDR: 3004007782-2019-00005). UPDATE: PATIENT EXPERIENCING RETURNING/CONTINUING INFECTION IN THE AFFECTED AREA. PHYSICIAN RECOMMENDATION IS TO EXPLANT THE EII SYSTEM DUE TO COMPLICATIONS OF THE INFECTION. EXPLANT HAS NOT YET OCCURRED DUE TO COVID-19 PANDEMIC/CONCERNS. ANTIBIOTIC TREATMENT WAS ORIGINALLY USED TO CLEAR UP THE INFECTION, HOWEVER IT SEEMS TO HAVE RETURNED. PHYSICIAN STATES THAT DIABETES IS LIKELY A MAJOR CONTRIBUTING FACTOR.
ENVOY MEDICAL CORP. (EMC) WAS NOTIFIED ON (B)(6) 2019 OF A PATIENT THAT EXPERIENCED PERIOPERATIVE, SURGICAL INCISION SITE INFECTION, POST BATTERY CHANGE. PATIENT WAS TREATED BY PATIENT'S LOCAL ENT WITH A COURSE OF ANTIBIOTICS AND THE INFECTION WAS CLEARED. NO DEVICE DEFICIENCIES ARE ALLEGED. PATIENT/CLINICAL HISTORY WITH EMC: (B)(6) - IMPLANT. (B)(6) - ACTIVATION. (B)(6) - FITTING. (B)(6) - FITTING. (B)(6) - FITTING. (B)(6) - FITTING. (B)(6) - FITTING AND REMOTE SUPPORT. (B)(6) - BATTERY CHANGE. (B)(6) - EMC NOTIFIED OF SURGICAL INCISION SITE INFECTION (MDR: 3004007782-2019-00005). (B)(6) - ESTEEM II SYSTEM EXPLANT. UPDATE: PATIENT EXPERIENCING RETURNING/CONTINUING INFECTION IN THE AFFECTED AREA. PHYSICIAN RECOMMENDATION IS TO EXPLANT THE EII SYSTEM DUE TO COMPLICATIONS OF THE INFECTION. EXPLANT HAS NOT YET OCCURRED DUE TO COVID-19 PANDEMIC/CONCERNS. ANTIBIOTIC TREATMENT WAS ORIGINALLY USED TO CLEAR UP THE INFECTION, HOWEVER IT SEEMS TO HAVE RETURNED. PHYSICIAN STATES THAT DIABETES IS LIKELY A MAJOR CONTRIBUTING FACTOR. UPDATE (2): PATIENT HAS BEEN EXPLANTED (B)(6) 2020 AS EXPECTED (NOTED IN UPDATE/FOLLOW UP MDR #1).
DEVICE EVALUATION SUMMARY: TEST RESULTS FROM DEVICE MANUFACTURING AND DHR WERE REVIEWED. ALL COMPONENTS IN QUESTION PASSED ALL FUNCTIONAL TESTING IN PRODUCTION AND PASSED QUALITY INSPECTIONS. NO ANOMALIES ASSOCIATED WITH STERILIZATION OF PRODUCT. NO DEVICE FAILURES ARE ALLEGED. (B)(4).
ENVOY MEDICAL CORP. (EMC) WAS NOTIFIED ON (B)(6) 2019 OF A PATIENT THAT EXPERIENCED PERIOPERATIVE, SURGICAL INCISION SITE INFECTION, POST BATTERY CHANGE. PATIENT WAS TREATED BY PATIENT'S LOCAL ENT WITH A COURSE OF ANTIBIOTICS AND THE INFECTION WAS CLEARED. NO DEVICE DEFICIENCIES ARE ALLEGED. PATIENT/CLINICAL HISTORY WITH EMC: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738772 | ESTEEM | ESTEEM II, PRODUCT CODE: OAF | OAF | ENVOY MEDICAL CORPORATION | 2001 | EMC0006353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |