MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 DR; PACEMAKER

Model Number 407152

Device Problems Pacing Intermittently (1443); Ambient Noise Problem (2877)

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

Event Date 05/29/2023

Event Type  malfunction  

Event Description

This device was explanted due to persistent noise on both channels and inhibited pacing.Should additional information be received, this file will be updated.

Manufacturer Narrative

The pacemaker and the right ventricular lead were received for analysis.The right atrial lead was not returned.Prior to the analysis of the returned devices, the quality documents accompanying the manufacturing processes for the pacemaker and the leads were re-investigated.All production steps were performed accordingly.In particular, the final acceptance tests proved the devices functions to be as specified.Upon receipt, the returned lead solia s 60 was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical, electrical and x-ray inspection.The returned lead proved to be without fault throughout its inspection.In particular, the values of the parameters measured during the electrical and mechanical analysis were within the technical specifications.The provided x-ray image was analyzed.An interaction between both leads in the implanted state cannot be excluded.The pacemaker was interrogated using a programmer device.The interrogation was properly feasible, however, noise was present in the right atrial and right ventricular channels, as mentioned in the complaint and observed on the returned data.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.The impedance measurement functions were also normal.A sensing test was performed, which did not provide the expected results.Therefore, the pacemaker was opened and subjected to a thorough destructive analysis.The visual inspection of the inner assembly showed no anomalies.The battery was fully charged.Subsequent thorough investigations revealed a damaged integrated circuit on the electronic module, which led to the clinical observation.In summary, inspection of the returned lead showed no anomalies.The clinical observation resulted from a damaged integrated circuit on the electronic module of the pacemaker.The manufacturing records document a flawless device production.It is therefore assumed that the damage occurred after the device shipment, however, the date of occurrence was not determinable.

• Brand Name: EDORA 8 DR
• 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: 17067156
• MDR Text Key: 316701285
• Report Number: 1028232-2023-02780
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 407152
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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