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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 Failure to Capture (1081)
Patient Problems Syncope (1610); Death (1802); Dizziness (2194)
Event Date 02/28/2018
Event Type  Death  
Event Description
It was reported that on (b)(6) 2018 patient presented to the emergency room with syncope, dizziness and hr in the (b)(6). The ekg on arrival showed failure to capture. Patient was given multiple doses of atrophine with no success and externally paced. The cath lab was being prepared with a temporary pacer however patient arrested and coded for an hour. Patient was given epinephrine as well as being intubated. Lab results found patient to be in renal failure with a creatinine of 7. 3 and a potassium of 7. 0 noted as likely the cause of the patients arrhythmia. Patient received gluconate however was still unresponsive. Patients blood pressure kept decreasing and when they could not feel a pulse, cpr was started and unsuccessful. Patient expired. Physicians final report stated acidosis/hyperkalemia and renal failure as cause of death. The death certificate shows complications of existing medical conditions as cause of death.
 
Manufacturer Narrative
The device is currently not available for analysis. No conclusion can be drawn at this time. The investigation will be re-opened should additional data become available.
 
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Brand NameETRINSA 8 HF-T
Type of DeviceCRT-P
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin D-123 59
GM D-12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key7889037
MDR Text Key120714961
Report Number1028232-2018-03169
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number394919
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 Received09/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2015
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: 09/19/2018 Patient Sequence Number: 1
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