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

Model Number 371992

Device Problems Premature Elective Replacement Indicator (1483); No Pacing (3268)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

After an implantation period of approx.105 months, it was reported that the device was explanted due to eri and not delivering pacing.Should additional information be received, 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) 2022.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.Besides that, the last follow-up was documented to be in (b)(6) 2014 and the capture control was found deactivated since (b)(6) 2017 as a result of the exceeding the maximum of loss of capture detections within 24 hours.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 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 the displayed message during interrogation.During the further course of the analysis, the header of the device was analyzed.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.All dimensions of the header bores were within the range requested by the is-1 standard specifications.Also, the spring elements of the pacemaker did not show any deviations.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 eri mode.Please note that with eri battery status the programmed heart rate is reduced by 11 percent and the device is operating in vdd mode.In addition, in vdd mode, in order to support av synchronized heart rhythm, the basic interval can be prolonged by the av delay, which may result in a lower heart rate.An additional long-term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.There was no intermittent or permanent loss of output.In conclusion, the device is fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: ENTOVIS DR-T PROMRI
• 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: 15965314
• MDR Text Key: 305452030
• Report Number: 1028232-2022-06337
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950037
• 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: 06/12/2023

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: 07/31/2015
• Device Model Number: 371992
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• 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