MAUDE Adverse Event Report: ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1688TC

Device Problem High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2012

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6)2012 and repositioned on (b)(6)2012 due to elevated thresholds.Sensing r-waves was 1.6 mv and there was no harm to the patient.The procedure took place at (b)(6)hospital with dr.(b)(6).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): ST. JUDE MEDICAL
• MDR Report Key: 17531624
• MDR Text Key: 321184267
• Report Number: MW5138537
• 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: 1688TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1