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

Model Number CD3357-40C

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 01/28/2015

Event Type  Injury  

Event Description

It was reported that the patient had a partial pocket incision dehiscence with development of hematoma while at home.The patient presented to the hospital and the hematoma was evacuated.Cultures were negative at that time.The patient later developed purulent drainage and the device was removed.All blood cultures were negative, however one pocket culture showed staph infection.A new system was implanted one week later.

Manufacturer Narrative

Udi (di): (b)(4).Analysis was normal.No anomaly was found.

• Brand Name: UNIFY ASSURA DR 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: 4740395
• MDR Text Key: 5704085
• Report Number: 2938836-2015-04121
• 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

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: CD3357-40C
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• 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: 71 YR