MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PROMOTE+ CRT-D W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3211-36Q

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

Patient Problem Pericardial Effusion (3271)

Event Date 04/11/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a post-explant patient developed pericardial effusion and had subxiphoid window procedure with drain placed.The patient was submitted into intensive care and was diagnosed with cardiogenic shock.The patient was stable at the time of the discharge.

• Brand Name: PROMOTE+ CRT-D W/SJ4 CONNECTOR
• 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: 5039767
• MDR Text Key: 24514910
• Report Number: 2938836-2015-29229
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Reporter Occupation: Physician
• Report Date: 07/13/2015

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: 04/30/2011
• Device Model Number: CD3211-36Q
• Device Lot Number: 2872977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2009
• 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: 64 YR