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

Model Number 1488T

Device Problem High Capture Threshold (3266)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

Technical services received a call on 07/24/2012 from sales rep.The lead was implanted on (b)(6) 2011.Patient had pocket revision scheduled due to weight loss and pg causing discomfort.Rv threshold had risen to 2.8v at 2ms so previously existing rv r/s lead model 1499t was connected to the pg.No physician or hospital known.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: 17530253
• MDR Text Key: 321409480
• Report Number: MW5137173
• 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: 08/10/2012

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
• Device Model Number: 1488T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1