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

Model Number 5820

Device Problems Fracture (1260); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported: if applicable, please provide details of what happened to the patient or product in connection with this event.On (b)(6) 2005, the first implantation was performed with kappadr and 5554, 5054.In 2014, it was replaced with the zepher dr5820 from abbott company.Since there was an abnormality in the lead impedance in the bipolar during normal follow-up, the polarity setting was changed to unipolar.At the time of this replacement procedure, a complete fracture of the atrial lead in the pocket was confirmed by cine image.Azuredr was connected and operated in wi mode at the judgment of the physician that removal was also a risk.Since the patient used a non- medtronic device and followed-up at a different hospital, and there was no record in the patient's medical record, details such as when the lead failure started or when the lead was completely fractured were unknown.The device was not defective.Event description: zephyr dr 5820 model number: 5820 serial or lot number: (b)(6).Please provide information related to the event and describe the product defect.No special note.Not a defective product.Removed - completely.Date of implantation (b)(6) 2014.Date of removal (b)(6) 2021.What is the status of the product return? (b)(4).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: 17531549
• MDR Text Key: 321422255
• Report Number: MW5138462
• 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: 04/05/2021

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: 5820
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1