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 Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2020

Event Type  malfunction  

Event Description

This device was explanted and replaced due to eri caused by lv lead at max outputs from lack of cs branches.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 one month remaining service time to the eri battery status.The archive data and the programmed parameters were inspected.High left venttricular pacing outputs of 7.0 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
• MDR Report Key: 9982971
• MDR Text Key: 188404855
• Report Number: 1028232-2020-01781
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 04035479147563
• UDI-Public: 04035479147563
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 407137
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 04/27/2020; 07/21/2020
• Supplement Dates FDA Received: 04/29/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR