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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 06/11/2018
Event Type  malfunction  
Event Description
This device was explanted and replaced due to eri 20 months after implantation. No adverse patient events were reported. Should additional information become available, this file will be updated.
 
Manufacturer Narrative
The pacemaker was returned and analyzed. The memory content demonstrated a normal functionality of the device while implanted and in service. The ability of the device to deliver therapies was verified. The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed. There was no indication of a device malfunction. In agreement with the clinical observation, the device interrogation revealed the battery status eri. The archive data and the programmed parameters were inspected. High left ventricular pacing outputs of 6. 0 v and 1,5 ms were documented in the archive data. This represents a high current program, which results in a faster discharge of the battery. The amount of charge taken from the battery was verified and the battery condition was found to be as expected. In conclusion, the pacemaker was fully functional. The battery status was anticipated.
 
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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 Key7656949
MDR Text Key112996728
Report Number1028232-2018-02271
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
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number394919
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2016
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: 07/02/2018 Patient Sequence Number: 1
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