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

Model Number 460160

Device Problems Failure to Capture (1081); High impedance (1291); Ambient Noise Problem (2877)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

This atrial leads showed impedance >2500 ohms, no capture at max output and noise.The patient was opened and the lead disconnected from the device.All testing of the lead produced good numbers so the lead was reconnected to the device.All measured values remained good so the patient was closed with leads and device active.Should additional information be received, this file 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: 18553332
• MDR Text Key: 333372117
• Report Number: 1028232-2024-00368
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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
• Date Manufacturer Received: 01/19/2024
• Date Device Manufactured: 09/05/2023
• 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
• Patient Outcome(s): Hospitalization