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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 Septic Shock (2068)
Event Date 11/30/2018
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 septic shock. The patient was hospitalized. Blood tests, urine tests, tte, thoracic ct, abdominal and pelvic ultrasound were done for diagnostic reasons. There was no mention of intervention.
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Brand NameENITRA 8 HF-T QP
Type of DeviceCRT-P
Manufacturer (Section D)
woermannkehre 1
berlin D-123 59
GM D-12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
MDR Report Key8336345
MDR Text Key136044997
Report Number1028232-2019-00558
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
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 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
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 Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2018
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: 02/13/2019 Patient Sequence Number: 1