MAUDE Adverse Event Report: 3M HEALTHCARE MEDIA, ELECTROCONDUCTIVE

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pacemaker generator/ component exchange pre- surgery + 15 minute surgical delay; during set up for case, the aex displayed a red light indicating poor return pad connection.Staff tried multiple return pads, all 3m9165 coreded rem pad.They also tried repositioning the pads, which eventually resolved the issue.It is unknown if any other interventional measures were taken.Staff completed the case using the same aex and handpiece.The exact event date is unknown.Customer estimates this occured 3 months ago.Customer is keeping the generator at this time as they believe this is a grounding pad issue.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MEDIA, ELECTROCONDUCTIVE
• Type of Device: MEDIA, ELECTROCONDUCTIVE
• Manufacturer (Section D): 3M HEALTHCARE
• MDR Report Key: 17527109
• MDR Text Key: 321138670
• Report Number: MW5134044
• Device Sequence Number: 1
• Product Code: GYB
• 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
• Report Date: 01/01/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1