MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY QUADRA CRT-D, US MODEL, DF1COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40

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

Patient Problems Chest Pain (1776); Pleural Effusion (2010); Pneumothorax (2012)

Event Date 04/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that post crt-d implant, patient complained of breathing related chest pain.Left lung atelectasis was noted on x-ray.Upon further evaluation, pleural effusion was also observed.Fluid in pleural cavity and the presence of pneumothorax were observed.After symptomatic and conservative treatment, chest pain was significantly relieved and pleura effusion and atelectasis were resolved.Patient's condition was improved and the patient was discharged.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF1COMP
• 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: 5718882
• MDR Text Key: 47189656
• Report Number: 2938836-2016-04888
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: CD3249-40
• Device Lot Number: S000004790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• 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