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

Model Number 1788T

Device Problem Under-Sensing (1661)

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Event Description

This ra lead was implanted on (b)(6) 2008.A call to technical services on (b)(6) 2011 states that there is possible atrial undersensing.Not seeing ra markers while rvs are present and measured pwaves are around 1.4mv.Discussed anvrt, check if a egm is lined up with v egm, it was.Discussed valsalva vs raising lal to for av synch when rhythm resolved itself spontaneously, patient now apvp.Probable av nodal reentry tachy resolved spontaneously back to normal pacing.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: 17525818
• MDR Text Key: 321088047
• Report Number: MW5132759
• 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: 05/04/2011

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: 1788T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1