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

Model Number 1688T

Device Problems Signal Artifact/Noise (1036); Intermittent Capture (1080); Pacing Problem (1439); High Sensing Threshold (2574)

Patient Problems Tachycardia (2095); Syncope/Fainting (4411)

Event Type  Injury  

Event Description

It was reported that the patient with this right ventricular (rv) lead was admitted into the hospital following a syncopal episode.The local area field representative noted a recent inaease in rv lead threshold, intermittent loss of capture (loc), and pacing inhibition.Boston scientific technical services (ts) reviewed the provided electrocardiogram (ecg) and noted the non-sustained ventricular tachycardia (nsvt) events showed noise/artifact on the r-waves.The case was discussed with the patient's physician who suspects the intermittent noise is an early sign of compromised lead integrity.Additionally, the field noted the nsvt episodes were in fact noise, and the patient is being transferred to a different hospital for rv lead replacement.Besides hospitalization, there were no additional adverse patient effects reported.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: 17531529
• MDR Text Key: 321138342
• Report Number: MW5138443
• 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: 04/27/2022

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
• Device Lot Number: JU133937 OR JW118548
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1