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U.S. Department of Health and Human Services

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

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BIOTRONIK SE & CO. KG ENITRA 8 HF-T CRT-P Back to Search Results
Model Number 407142
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Battery shows eri, excess battery consumption. The device is already explanted and will be send to berlin for the analysis.
 
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Brand NameENITRA 8 HF-T
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 Key12519479
MDR Text Key273843345
Report Number1028232-2021-05217
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeDE
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 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model Number407142
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 Received09/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/23/2017
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: 09/23/2021 Patient Sequence Number: 1
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