MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number UNKNOWN

Device Problems Signal Artifact/Noise (1036); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Boston scientific received information stating: migrating international under far right under the arm.There has been external noise on both leads these leads are unipolar medtronic.No inhibition of pacing.No model or serial numbers were provided in regards to the medtronic leads.(b)(6) hospital (b)(6), australia no other details provided.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): MEDTRONIC
• MDR Report Key: 17523081
• MDR Text Key: 321332962
• Report Number: MW5130029
• 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: 08/10/2012

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: UNKNOWN
• Patient Sequence Number: 1