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

Model Number 1688T

Device Problem Failure to Capture (1081)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2012

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2007 and capped on (b)(6) 2011 due to loss of capture for 6-7 seconds in the rv.The patient was symptomatic to the loss of capture and was hospitalized until the lead could be revised.Impedance was within normal limits.The procedure took place at (b)(6) medical center 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: 17525003
• MDR Text Key: 321411129
• Report Number: MW5131945
• 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: 12/21/2012

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: 1688T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1