MAUDE Adverse Event Report: ST JUDE MEDICAL DURATA; 7122Q

Model Number 7112Q

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574); Folded (2630); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 12/30/2014

Event Type  Injury  

Event Description

St jude medical durata rv lead presented with noise and inappropriate therapy.It was extracted safely and found to have significant tearing away of the outer insulation in the pocket, as well as a bunching of the insulation at the distal tip.No extraction tools were needed to remove the lead.It was removed safely, put in a biohazard bag along with the device and given to the manufacturer to return for analysis.Reason for use: vt.

• Brand Name: DURATA
• Type of Device: 7122Q
• Manufacturer (Section D): ST JUDE MEDICAL
• MDR Report Key: 4408472
• MDR Text Key: 5275716
• Report Number: MW5040162
• 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: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7112Q
• 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?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 83