MAUDE Adverse Event Report: ST. JUDE MEDICAL INC., CRMD PROMOTE QUADRA; ICD

Model Number CD3239-40Q

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

Patient Problems Syncope (1610); Weakness (2145); Shock from Patient Lead(s) (3162)

Event Date 07/20/2012

Event Type  Injury  

Event Description

It was reported that the patient felt weakness and experienced syncope as well as multiple high voltage therapies.The device remained implanted.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.

• Brand Name: PROMOTE QUADRA
• Type of Device: ICD
• Manufacturer (Section D): ST. JUDE MEDICAL INC., CRMD; 15900 alley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL INC., CRMD; valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4053889
• MDR Text Key: 4735776
• Report Number: 2938836-2014-05910
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• 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: 08/31/2013
• Device Model Number: CD3239-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/25/2012
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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