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

Model Number 1888TC

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); No Pacing (3268)

Patient Problems Cardiac Arrest (1762); Foreign Body In Patient (2687)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2008 and was capped or abandoned on (b)(6) 2018.A product experience report was received on (b)(6) 2018 stating that this lead exhibited noise.In addition to that, oversensing and pacing inhibition with asystole of less than 2 seconds was observed.The physician was dr.(b)(6) at (b)(6) medical 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): ST. JUDE MEDICAL
• MDR Report Key: 17532376
• MDR Text Key: 321430258
• Report Number: MW5139284
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1888TC
• Patient Sequence Number: 1