MAUDE Adverse Event Report: MED PERMANENT PACEMAKER ELECTRODE

Model Number 4968

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013)

Event Type  Injury  

Event Description

Explant procedure was performed on (b)(6) and mr.(b)(6) who was a md, informed us at 14:00 on (b)(6) 2016.It was performed due to device erosion and infection was suspected.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT PACEMAKER ELECTRODE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MED
• MDR Report Key: 17525483
• MDR Text Key: 321052959
• Report Number: MW5132424
• Device Sequence Number: 1
• Product Code: DTB
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4968
• Patient Sequence Number: 1