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

Model Number 1488T

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Tachycardia (2095); Shock from Patient Lead(s) (3162)

Event Type  Injury  

Event Description

It was reported that a health care professional (hcp) called technical services (ts) for a review of data.Upon review, ts noted the cardiac resynchronization therapy defibrillator (crt-0) oversensed the respiratory rate trend (rrt) signal on a non-boston scientific right atrial (ra) lead however, it was not sensed or causing altered pacing function.Additionally, there was a stored signal artifact monitoring (sam) episode on the ra channel in which it was noted that the right ventricular (rv) lead pace impedances were high out of range measuring greater than 3000 ohms.Ts also found that this patient received inappropriate anti-tachycardia pacing (atp) and shock therapy due to supraventricular tachycardia (svt).The hcp will discuss with the clinic regarding device replacement.At this time, the device and non-boston scientific ra and rv leads remain in service.No adverse patient effects were 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: 17536052
• MDR Text Key: 321044999
• Report Number: MW5142944
• 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: 1488T
• Device Lot Number: DC70305
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1