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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 Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 04/02/2021
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
The patient suffered from a pocket hematoma and infection. The investigator assessed this event as possible related to the patients medication with warfarin. The patient was hospitalized and treated with antibiotics.
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Brand NameENITRA 8 HF-T QP
Type of DeviceCRT-P
Manufacturer (Section D)
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
MDR Report Key12301327
MDR Text Key265822545
Report Number1028232-2021-04488
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeDE
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number407141
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial