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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ENITRA 8 HF-T QP CRT-P

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BIOTRONIK SE & CO. KG ENITRA 8 HF-T QP CRT-P Back to Search Results
Model Number 407141
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/03/2021
Event Type  Injury  
Manufacturer Narrative
An infection was observed following the implantation of this biotronik device. The sterilization process was investigated. The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc. , are within its specified ranges for each distributed device. Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process. Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident. In summary, the infection was not device related.
 
Event Description
It was reported that this system was explanted due to infection.
 
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Brand NameENITRA 8 HF-T QP
Type of DeviceCRT-P
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key12860655
MDR Text Key281140932
Report Number1028232-2021-06394
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeDE
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2021
Device Model Number407141
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/23/2021 Patient Sequence Number: 1
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