MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ENTOVIS DR-T; PACEMAKER

Model Number 365463

Device Problem No Pacing (3268)

Patient Problem Asystole (4442)

Event Date 09/21/2022

Event Type  Injury  

Event Description

This device functioned normally during pre-procedure interrogation and was being upgraded.Device set to doo bipolar in both leads with lead check off to ensure pacing on a dependent patient.Pacing support was lost when device was removed with leads attached and patient experienced an asystole episode.Device was reinserted into pocket and pacing resumed.Device was explanted.Should additional information become available, this file will be updated.

Manufacturer Narrative

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 visually inspected revealing burn marks on the pacemaker can most likely resulting from the use of an electrocautery tool.Next, during initial interrogation the device was operating in a safety backup mode and the programmer prompted a re-initialization request.The pacemakers memory content was inspected.The inspection revealed that the device switched into the safety backup mode on september 21, 2022, as a result of the detection of invalid memory content.By design, the pacemaker performs self-checks and is equipped with the ability to detect and repair invalid memory content.However, in the case of multiple invalid memory areas, the device cannot correct the memory content and switches into the safety backup mode to ensure patient safety.While in this safety program, the pacemaker is capable to deliver anti-bradycardia therapies in unipolar lead configuration.Upon interrogation a device status error message appears to notify the user.Please note that in unipolar configuration sufficient tissue contact is necessary for effective stimulation.The activation of the safety backup mode does not indicate a material or manufacturing problem.This is supported by the fact that after a re-initialization, the ram application was operating as expected.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 conclusion, the clinical observation resulted from invalid memory content.The root cause for the invalid memory content was not determinable.However, external influences such as strong electromagnetic fields could be taken into consideration.After a re-initialization the device was operating as specified.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: ENTOVIS DR-T
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15554763
• MDR Text Key: 301336046
• Report Number: 1028232-2022-05173
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• 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
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: 365463
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2013
• 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: 64 YR
• Patient Sex: Male