MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ELUNA 8 DR-T PROMRI; PACEMAKER

Model Number 394969

Device Problems Intermittent Capture (1080); Unstable Capture Threshold (3269)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

This device was explanted due to intermittent rv capture and increasing rv thresholds.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device 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, and the memory content was analyzed indicating no anomalies.The battery status was found to be greater than 50 percent.Home monitoring data were analyzed which documented slight rv lead impedance fluctuations between 500 ohms and 600 ohms.Capture control and lead check were found to be deactivated since (b)(6) 2021.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 standard specifications.Also, the spring elements of the pacemaker did not show any deviations.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.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: ELUNA 8 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: 16177261
• MDR Text Key: 307506647
• Report Number: 1028232-2023-00208
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 04035479131937
• UDI-Public: (01)04035479131937(17)181231
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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: 12/31/2018
• Device Model Number: 394969
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• 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: 71 YR
• Patient Sex: Female