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

Model Number CD3231-40Q

Device Problem Failure to Interrogate (1332)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)

Event Date 10/29/2014

Event Type  Injury  

Manufacturer Narrative

The initial medical device report was submitted (2938836-2014-19366).(b)(4).Lithium clusters were observed during the analysis.No additional analysis is necessary.

Event Description

It was reported that the device could not be interrogated.All troubleshooting were unsuccessful in attempt to interrogate the device.The device was explanted and replaced.The patient exhibited symptoms of cardiogenic shock prior to the procedure, but was in stable condition following the device replacement.New information received notes that prior to replacement of the device the patient experienced dyspnea.New information received notes that prior to replacement of the device the patient experienced dyspnea.

• 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: 7377584
• MDR Text Key: 103696442
• Report Number: 2017865-2018-04397
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2011
• Device Model Number: CD3231-40Q
• Device Catalogue Number: CD3231-40Q
• Device Lot Number: 3123462
• Other Device ID Number: 05414734504393
• Date Manufacturer Received: 03/01/2018
• Date Device Manufactured: 04/16/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1