MAUDE Adverse Event Report: ST. JUDEDURATA

Model Number 7120

Event Date 04/18/2012

Event Type  Injury   Patient Outcome  Required Intervention

Event Description

Non invasive programmed stimulation of icd, revealed undersensing of ventricular fibrillation after induction. Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead.

• Brand Name: DURATA
• Type of Device: DURATA
• Manufacturer (Section F): ST. JUDE
• Manufacturer (Section D): ST. JUDE
• Device Event Key: 2592280
• MDR Report Key: 2561677
• Event Key: 2523216
• Report Number: MW5025285
• Device Sequence Number: 1
• Product Code: LWS
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/02/2012
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device MODEL Number: 7120
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes

Is this an Explanted Device?