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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ETRINSA 8 HF-T CRT-P
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BIOTRONIK SE & CO. KG ETRINSA 8 HF-T CRT-P Back to Search Results
Model Number 394919
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2019
Event Type  malfunction  
Event Description
This device was explanted and replaced due to eri from lv lead with high thresholds and is programmed to 6. 5v at 1. 0ms. No adverse patient events were reported. Should additional information become available, this file will be updated.
 
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Brand NameETRINSA 8 HF-T
Type of DeviceCRT-P
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key9187387
MDR Text Key162555003
Report Number1028232-2019-04451
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Model Number394919
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2016
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: 10/14/2019 Patient Sequence Number: 1
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