MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 HF-T QP; CRT-P

Model Number 407137

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

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.

Event Description

This device was explanted due to eri.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

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 5.0 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.

• Brand Name: EDORA 8 HF-T QP
• Type of Device: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12750669
• MDR Text Key: 280077993
• Report Number: 1028232-2021-05951
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 04035479147563
• UDI-Public: (01)04035479147563(17)190930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 407137
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 94 YR
• Patient Sex: Female