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

Model Number 1688T

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291)

Patient Problem Bradycardia (1751)

Event Date 10/03/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, patient was admitted to the hospital due to symptomatic bradycardia.Upon interrogation of the device, rv lead was not capturing at 6.5v at 1 msec.Impedance was greater than 2500 ohms.X-ray shows lead fracture.New system being implanted on the left side on (b)(6) 2013.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6), australia.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): ST. JUDE MEDICAL
• MDR Report Key: 17527263
• MDR Text Key: 321135185
• Report Number: MW5134196
• 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

• 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