MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3235-40Q

Device Problems Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 06/29/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient expired.While transporting the patient to the hospital, the patient went into cardiopulmonary arrest and expired upon arrival.The therapy was set to off.The device delivered therapy for a sustained vt; however, the heart muscle was too exhausted to beat again.Review of the ecg revealed undersensing of a vf episode, which was suspected to be the cause of the patient's death.No further information is available.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5827798
• MDR Text Key: 50611991
• Report Number: 2938836-2016-06497
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: CD3235-40Q
• Device Lot Number: 3856822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2012
• 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): Death