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

Model Number JT45

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2016

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 2012 and was capped on (b)(6) 2016 due to impedance of 3000 ohms and verified fracture.The physician was dr.(b)(6) at (b)(6) center in (b)(6).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): SORIN
• MDR Report Key: 17531668
• MDR Text Key: 321250636
• Report Number: MW5138581
• 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: 01/12/2017

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: JT45
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1