MAUDE Adverse Event Report: BIOTRONIK SIELLO S 60; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SOLIA 60

Device Problems Fracture (1260); Low impedance (2285); High Capture Threshold (3266)

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

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead exhibited low pacing impedance (less than 200 ohms), lead safety switch in unipolar settings, and high thresholds 7.5v at 1 ms.The physician believes there to be a rv lead fracture.The patient is not pacing on the ventricular lead.Remains implanted.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIELLO S 60
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17490038
• MDR Text Key: 320696837
• Report Number: MW5122556
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: SOLIA 60
• Patient Sequence Number: 1