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

Model Number 460160

Device Problems Impedance Problem (2950); Unstable Capture Threshold (3269)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

A few hours after the operation, an rv pacing failure occurred, the lead position on fluoroscopy was unchanged, and the threshold was unstable.Iegm data analysis showed unstable pacing thresholds and impedances.Device currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The ipg and the lead under complaint were not returned for analysis.The analysis is therefore based on the inspection of the returned device data as well as the quality documents associated with the manufacture of this particular device.The manufacturing process for these devices 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 for the ipg and the lead proved the device functions to be as specified.The returned device data have been analyzed.Analysis of the available iegms showed repeated sequences of pacing events followed by two sensing signals of different morphology in all iegms.Analysis of the corresponding sensing signals indicates that the pacing event with the set parameters most likely did not result in effective stimulation of the myocardium.As a consequence, self-excitation was perceived shortly after the pacing event.The available device data further showed documented pacing threshold tests indicating unstable pacing thresholds of up to 4.6v.In addition, bipolar and unipolar ventricular pacing impedances of 957ohms and 684ohm, respectively, were documented.Based on the available information, no conclusion can be drawn regarding the root cause of the clinical observation.However, it cannot be excluded that the electrical connection between the lead and the ipg, micro lead dislodgement or an acutely unfavorable lead position might have led to the clinical observation.Analysis of the available data, however, revealed no indication of an ipg malfunction.Should additional relevant information become available, the investigation will be updated.

• Brand Name: AMVIA SKY DR-T
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17780722
• MDR Text Key: 323831270
• Report Number: 1028232-2023-04660
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: DE
• 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
• Report Date: 09/20/2023

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 Model Number: 460160
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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