MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA + EXCELIS ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3385-40QC

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2017

Event Type  malfunction  

Event Description

It was reported that the implantable cardioverter defibrillator's header was discolored.The device was not used.

Manufacturer Narrative

The reported field event of header discoloration was confirmed in the laboratory.However, the cloudy appearance was found to be acceptable since all the header components and the tip of the test leads were visible through the header.The device was tested on the bench and using automated testing equipment and no anomalies were found.

• Brand Name: QUADRA + EXCELIS ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7143780
• MDR Text Key: 95667729
• Report Number: 2017865-2017-36612
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: CD3385-40QC
• Device Lot Number: P000042104
• Other Device ID Number: 05414734508568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2017
• 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