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

Model Number 407141

Device Problem Failure to Interrogate (1332)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that the device is not interrogable.The pacemaker was replaced.

Manufacturer Narrative

Implant date corrected from (b)(6) 2023 to (b)(6) 2018.The pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was interrogated.The interrogation of the device was properly feasible and showed the eri battery status, confirming the clinical observation.The eri battery status was triggered on (b)(6) 2023.In addition, a warning message was displayed on the programming device as mentioned in the complaint description.The memory content of the device was thoroughly inspected.First, the amount of charge taken from the battery with respect to the battery state was verified, revealing the eri battery status to be normal and as expected.Further investigation of the available device data showed the detection of a left ventricular lead failure on (b)(6) 2023, leading to a left ventricular vector switch from lv1 tip - lv4 ring to lv1 tip - can and the automatic deactivation of capture control in the right ventricle.In addition, high left ventricular pacing output was noted of up to 3.0 v and 1.5 ms, which represents a high current consumption program, resulting in a faster battery discharge.In a next step, 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.The current consumption was normal and as expected.In addition, the impedance measurement functions of the device were tested and proved to be fully functional.All measured impedances were normal and as expected.In conclusion, thorough analysis of the device and the available device data revealed no indication of a device malfunction.

• Brand Name: ENITRA 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: 18256999
• MDR Text Key: 329612125
• Report Number: 1028232-2023-06116
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: 407141
• 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: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• 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