MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Dyspnea (1816); Ventricular Tachycardia (2132)

Event Date 11/05/2014

Event Type  Death  

Event Description

It was reported that the patient presented to the emergency room with increasing dyspnea, syncope, and chest discomfort.The patient went into a sustained ventricular tachycardia while in the er and was treated with medication.Patient was admitted to icu with no further vt at this time but was experiencing symptoms of cardiogenic shock.It was determined that a ventricular assist device (vad) should be implanted.The patient could not tolerate lying flat and was intubated due to shortness of breath.During placement of a central venous catheter, the patient went into vt.Acls protocol was initiated.The patient returned to spontaneous circulation after about four minutes.An arterial line was placed; hematoma was noted at this site.The patient was reported to have some seizure activity/posturing and anti-seizure meds were administered.Implant of the vad was then completed.The patient went into pea rhythm and after chest compressions were started, the family requested the compressions to stop.The patient expired.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.(b)(4).

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4367651
• MDR Text Key: 5238281
• Report Number: 2938836-2014-19294
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: CD3231-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2011
• 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
• Treatment: 7070/AEE12382,1699TC/EN016624,1258T/BLG046024
• Patient Outcome(s): Death
• Patient Age: 56 YR