MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH RECORDING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

It was reported that there were issues with pacing through their siemens recording system.Per sf wo-01076708; attended site to investigate reports that high impedance is happening while pacing through the non-boston scientific recording system.Tested micropace was pacing ok using leads.No issues seen with micropace system.Investigated set up of recording system and found some set ups for pacing did not have bipolar channels selected.Selected bipolar channels.Pacing was tested through non-boston scientific recording system with no issues seen.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RECORDING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 18021349
• MDR Text Key: 327135802
• Report Number: MW5147348
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Type of Device Usage: A
• Patient Sequence Number: 1