MAUDE Adverse Event Report: PACESETTER PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1488TC

Device Problem No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2003 and remains implanted at this time.A call to technical services placed on 10/24/2013 stated that the patient paces only 1-2% in the ventricle.Thresholds is 1 v in manual and 1.1 v in auto.The output is 3.5 v.Technical services stated that the autocapture operates on a beat-to-beat basis and if there is loss of capture, it goes to 1.5 times the previous thresholds but at minimum of 3.5 v.Clinician reviewed the daily trend for thresholds and it has been steady at 1.0-1.1 v.Clinician will program to a fixed value for now.No other information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): PACESETTER
• MDR Report Key: 17532621
• MDR Text Key: 321460858
• Report Number: MW5139528
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 12/17/2013

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: 1488TC
• Patient Sequence Number: 1