MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE PACESETTER; THE GENERATOR

Model Number V243

Device Problems Nonstandard Device (1420); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 05/13/2016

Event Type  Injury  

Event Description

Surgical explantation of icd system including laser lead extraction for 13 yr old right atrial and right ventricular leads.One of the leads is malfunctioning and is on manufacturer recall (st.Jude medical riata).

• Brand Name: ST. JUDE PACESETTER
• Type of Device: THE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul MN 55117
• MDR Report Key: 5675341
• MDR Text Key: 45874907
• Report Number: MW5062448
• Device Sequence Number: 3
• Product Code: DTB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/19/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR