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

Model Number 407141

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 09/20/2021

Event Type  malfunction  

Event Description

Device explanted due to unexpected eri.In june during follow up 25 percent battery was recorded.

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 in eri mode.There was no indication of a device malfunction.In agreement with the clinical observation, the device interrogation revealed the battery status eri which was activated on 18-jul-2021.The archive data and the programmed parameters were inspected.High right ventricular and left ventricular pacing outputs of 4.4v 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.Please note, the pacing percentage of the remaining battery capacity is the remaining capacity until eos.In conclusion, the pacemaker was fully functional.The battery status was anticipated.

• Brand Name: ENITRA 8 HF-T QP
• Type of Device: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12619747
• MDR Text Key: 276112784
• Report Number: 1028232-2021-05598
• Device Sequence Number: 1
• Product Code: NKE
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 407141
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization