• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

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.
Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance. As of today, the medical device is not available for analysis, therefore the device itself could not be investigated. The information you provided has been entered into our quality system as a complaint. These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices. Should additional relevant information or the device itself become available, the investigation 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. The device interrogation revealed the battery status - ok - with 20 percent remaining battery capacity. The archive data and the programmed parameters were inspected. High left ventricular pacing outputs of 6. 5v and 1. 0ms 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 condition was anticipated.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETRINSA 8 HF-T
Type of DeviceCRT-P
Manufacturer (Section D)
woermannkehre 1
berlin 12359
MDR Report Key9187387
MDR Text Key162555003
Report Number1028232-2019-04451
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 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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/14/2019 Patient Sequence Number: 1