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

Model Number CD3231-40Q

Device Problems Failure to Interrogate (1332); No Device Output (1435)

Patient Problems Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130)

Event Date 06/27/2014

Event Type  Death  

Manufacturer Narrative

The initial medical device report was submitted (2938836-2014-13599).Lithium clusters were observed during the analysis.No additional analysis is necessary.

Event Description

It was reported that the patient fell and went into cardiac arrest.Paramedics arrived 14 minutes later and discovered that the patient was in vf and delivered two external defibrillation therapies.Patient had electrical activity but no pulse.Cpr was performed for 40 minutes.The patients rate later stabilized at 90 bpm but a ct scan appeared to show no brain activity.No device image could be obtained and the device exhibited no telemetry.Damage due to external defib was suspected.Device explant was recommended, but the physician wanted to wait until the patient stabilized.It was later reported that the patient expired.The patient had experienced further vf episodes and bradycardia with no resultant device based therapy evident.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7382689
• MDR Text Key: 103863695
• Report Number: 2017865-2018-04657
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2013
• Device Model Number: CD3231-40Q
• Device Catalogue Number: CD3231-40Q
• Device Lot Number: 3488503
• Other Device ID Number: 05414734504393
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/29/2018
• Date Device Manufactured: 09/05/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1