MAUDE Adverse Event Report: ST. JUDE MEDICAL TENDRIL STS PACING LEAD; LEAD, PACEMAKER

Model Number 2088TC

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

Patient returned to the or for insertion of permanent pacemaker after open heart procedure.Surgical procedure went well.Before transporting patient off the or bed, it was noted ventricular lead was not functioning.Patient re-prepped and draped and ventricular lead was explanted and a new lead placed.Patient transported to nursing unit in stable condition.

• Brand Name: TENDRIL STS PACING LEAD
• Type of Device: LEAD, PACEMAKER
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st paul MN 55117
• MDR Report Key: 4823681
• MDR Text Key: 5910026
• Report Number: 4823681
• Device Sequence Number: 1
• Product Code: DTB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 2088TC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2015
• Patient Sequence Number: 1
• Patient Age: 46 YR