MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC DURATA DF-4 LEAD; RV LEAD

Model Number 7122Q

Device Problems Signal Artifact/Noise (1036); Degraded (1153); Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)

Patient Problem Electric Shock (2554)

Event Date 12/30/2014

Event Type  Injury  

Event Description

A st.Jude medical durata df-4, model #: 7122q, sn: (b)(4) was implanted (b)(6) 2010.This lead was found to have repetitive noise sensing, especially with pocket manipulation.The patient was inappropriately shocked twice because of this noise sensing.The patient underwent an extraction of this lead and upon inspection was found to have an outer insulation breakdown of the outer optim insulator at bend point of 180 degrees underneath the icd can suggesting can on lead erosion.The lead was successfully extracted without complications.

• Brand Name: DURATA DF-4 LEAD
• Type of Device: RV LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; one st. jude medical dr; st. paul MN 55117 998
• MDR Report Key: 4465858
• MDR Text Key: 5189441
• Report Number: MW5040427
• Device Sequence Number: 1
• Product Code: NVY
• 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: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 83