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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 Hematoma (1884)
Event Date 05/10/2019
Event Type  Injury  
Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.The device is currently not available for analysis.Therefore, no conclusion can be drawn at this time.However, biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.Should additional relevant information become available, this investigation will be updated.
 
Event Description
The patient suffered from bleeding in the device pocket after crt-p implantation due to marcumar therapy (anticoagulants) and a pocket hematoma.A surgical intervention was done.Furthermore, marcumar was stopped and clindamycin 600 mg was started for prophylactic reasons.
 
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Brand Name
ENITRA 8 HF-T QP
Type of Device
CRT-P
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key8633756
MDR Text Key145851761
Report Number1028232-2019-02091
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P070008
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 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Model Number407141
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/21/2019
Initial Date FDA Received05/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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