MAUDE Adverse Event Report: MEDTRONIC RV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 5076

Device Problems High Sensing Threshold (2574); Impedance Problem (2950)

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

It was reported that the patient implanted with this right ventricular (rv) lead experienced a syncopal episode.The health care professional (hcp) contacted boston scientific technical services (ts) and noted that there was no remote interrogation from the date of the syncopal episode.Review of previous remote interrogation data noted pacing impedance measurements for this rv lead varied from the 500 ohms range to the 1,800 ohms range for the past year.Additionally, high threshold measurements were observed and outputs were noted to be programmed to a fixed output of 5 volts.The hcp planned to have the patient perform a remote interrogation.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17536832
• MDR Text Key: 321133408
• Report Number: MW5143715
• 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: 04/22/2020

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: 5076
• Patient Sequence Number: 1