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

Model Number 394969

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 09/23/2021

Event Type  malfunction  

Event Description

After an implantation period of approx.56 months, upon interrogation it was observed that the device shows incorrect device data.The device will be explanted.

Manufacturer Narrative

Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Next, the pacemaker was subjected to an electrical analysis, revealing that the device could not be properly interrogated, confirming the clinical observation.The inspection of the devices memory showed a severe invalid memory content.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal.The device operated in vvi mode with 50 bpm and 4.8 v at 1.0 ms.There was no indication of a device malfunction.During the further course of the analysis, the device was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The battery was found almost depleted.The electronic module was attached to an external power supply to test the functionality of the module.Thereby, the electrical parameters, particularly the current consumption of the electronic module were found to be normal and as expected.All therapy functions were available and worked as expected in the safety backup mode.Subsequently, using a technical programming tool, the device was reset showing a proper device functionality.The battery was sent to the manufacturer for further detailed analysis.The analysis is still ongoing.Should relevant information become available, the investigation will be updated.

• 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: 12600565
• MDR Text Key: 275506471
• Report Number: 1028232-2021-05562
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 04035479131937
• UDI-Public: 04035479131937
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 394969
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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