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

Model Number 1882TC

Device Problems Pacing Inadequately (1442); Patient-Device Incompatibility (2682); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 2012 and remains implanted.It was reported to technical services on (b)(6) 2012 that this patient fell 5 feet off of a ladder and the p-wave went from 3 to 7mv, ra threshold up from 0.9 to 1.1 v, impedance now 500 was 478.Discussed, pwave much larger than implant but other measurements wnl, ra pacing captured ra so prob better sensing with lead healing in myocardium.Rv threshold may also be normal range, will monitor for now.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: 17532982
• MDR Text Key: 321418703
• Report Number: MW5139888
• 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: 08/10/2012

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: 1882TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1