MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ABBOTT LOW VOLTAGE LEAD; No Match

Model Number LOW VOLTAGE LEAD

Device Problems Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508); Device Sensing Problem (2917)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

Voluntary event report was received.Medwatch: mw5153379, mw5153378.

Event Description

Voluntary medwatch received states that patient's atrial lead exhibited failure to capture, p wave amplitude variation and phrenic nerve stimulation.Programming changes were made.There were no patient consequences.

• Brand Name: ABBOTT LOW VOLTAGE LEAD
• Type of Device: No Match
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19217952
• MDR Text Key: 341457711
• Report Number: 2017865-2024-40125
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LOW VOLTAGE LEAD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1