MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3361-40C

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Syncope (1610)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.  based on the information received, the cause of the reported incident could not be conclusively determined, but was reported to be due to programming parameters.

Event Description

The patient presented to the emergency department with syncope.Interrogation of the device revealed four episodes of ventricular tachycardia (vt) and ventricular fibrillation (vf) without delivered therapy due to programming to the monitoring zone.After three minutes, the patient received antitachycardia pacing and high voltage therapy due in response to the polymorphic vt/vf, and returned to sinus rhythm.The device was programmed to a non-monitoring zone to resolve the issue and the patient was fine.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7079094
• MDR Text Key: 93599617
• Report Number: 2938836-2017-34551
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: CD3361-40C
• Device Lot Number: 4765821
• Other Device ID Number: 05414734508223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR