MAUDE Adverse Event Report: ST. JUDE MEDICAL DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 1258T

Device Problems Signal Artifact/Noise (1036); Under-Sensing (1661)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that decreased r-wave amplitude measurements and low right ventricular (rv) pacing impedance measurements of 500 ohms were observed.Additionally, review of stored device memory noted evidence of noise one month prior.It was noted that this left ventricular (lv) lead was connected to the right ventricular (rv) pace/sense port of the device header and the rv lead was connected to the lv port of the device header.Technical services (ts) reviewed the noise and discussed it appeared to be real lead noise and discussed troubleshooting options.Noise was unable to be reproduced in clinic with patient isometrics and lead measurements were noted to be stable.Ts recommended continued monitoring or the option to obtain an x-ray.No adverse patient effects were reported.This device remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17536114
• MDR Text Key: 321459409
• Report Number: MW5143004
• Device Sequence Number: 1
• Product Code: OJX
• 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: 02/07/2021

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: 1258T
• Patient Sequence Number: 1