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

Model Number 359529

Device Problems Premature Elective Replacement Indicator (1483); Device Displays Incorrect Message (2591)

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

Event Date 06/30/2021

Event Type  malfunction  

Event Description

Device explanted.Device stated there was an error other than battery depletion and to perform a memory dump and contact biotronik.Ram dump is attached for analysis.The clinician stated the device is eri and they were bringing in patient monthly to check for eri.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device was received and analyzed.Prior to the analysis of the device, the manufacturing process for this pacemaker was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the device was interrogated showing an alert on the programming device as mentioned in the complaint description.The eri battery status was triggered on (b)(6) 2021.The memory content of the device was thoroughly analyzed.The battery voltage and current consumption were found to be normal and as expected.The analysis further showed that a large amount of home monitoring transmission retries were documented in the device data, which can lead to a temporary increase of current consumption and a noticeable decrease of time to eri.In general, the current consumption of the device is influenced by different factors, which may lead to noticeable changes of tte indication.Such factors are, for instance, changes in lead impedance values or the programmed parameters, a prolonged follow-up session or even a large amount of hm transmission retries.The amount of charge taken from the battery was verified.The battery condition was found to be normal and as expected.After eri activation, the battery voltage temporarily recovered to a value above the eri threshold.This does not represent a battery malfunction but results in a displayed message during interrogation.Next, the pacemaker was subjected to an electrical analysis.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 summary, the pacemaker was fully functional.The battery condition was found to be normal and as expected.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: EVIA 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: 12323893
• MDR Text Key: 266603053
• Report Number: 1028232-2021-04610
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 04035479101312
• UDI-Public: 04035479101312
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 359529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR