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

Model Number 1488T

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

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this pacemaker device exhibited a high out of range pace impedance measurement greater than 3000 ohms on the right ventricular (rv) lead which triggered a lead safety switch (lss).As a result, the device automatically switched the rv lead from the bipolar to the unipolar pacing and sensing configuration.The rv lead is not a boston scientific product.Boston scientific technical services (ts) indicated that the rv pace impedance measurements have been relatively stable in the 500 ohm to 700 ohm range with a recent high, but within specification, measurement of 1738 ohms occurring a few days prior to the high out of range measurement.Ts discussed with the healthcare provider (hcp) that this is not likely an issue with a device set screw or the lead not being fully inserted into the device header, but it could be a lead conductor fracture or a device header spring contact issue.Ts provided guidance to consider bringing the patient into the clinic to reprogram the rv lead back to a bipolar configuration and perform isometric testing.If there is a lead fracture, ts indicated that they should observe high out of range pace impedance measurements during the isometric testing.If not, then it could be a device header spring contact issue for which the suggestions would be to reprogram the rv lead to a unipolar pacing and bipolar sensing configuration.Ts also suggested an x-ray be performed since the leads have been in-service for approximately fourteen (14) years.The products remain in-service.There were no patient symptoms or 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: 17534374
• MDR Text Key: 321189368
• Report Number: MW5141276
• 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: 08/19/2020

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