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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 02/14/2020
Event Type  malfunction  
Event Description
Device explanted due to eri, which was reached due to high lv threshold and the rv lead not being optimized.No adverse patient events were reported.Should additional information become available, this file will be updated.
Manufacturer Narrative
An infection was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the infection was not device related.
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 right and left ventricular pacing outputs of up to 5.4 v and 1.0 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 Name
Type of Device
Manufacturer (Section D)
woermannkehre 1
berlin 12359
MDR Report Key9730069
MDR Text Key180810371
Report Number1028232-2020-00835
Device Sequence Number1
Product Code NKE
UDI-Device Identifier04035479131777
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Model Number394919
Device Catalogue NumberSEE MODEL NO.
Date Manufacturer Received04/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;