MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 06/14/2019

Event Type  Death  

Event Description

Related manufacturer reference number:2017865-2019-13281, related manufacturer reference number:2017865-2019-13292, related manufacturer reference number:2017865-2019-13293.It was reported that the patient deceased.There is no known allegation from a health professional that suggests the death was related to the device.The reported cause of death was cardiopulmonary arrest.

Manufacturer Narrative

A partial lead was returned for analysis in one piece measuring 7.5 cm.The damage found was sustained during the surgical procedure.The portion of the lead that was returned was otherwise normal.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8972887
• MDR Text Key: 156866950
• Report Number: 2017865-2019-13294
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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: 01/31/2016
• Device Model Number: 1458Q/86
• Device Lot Number: 3918674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2013
• 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): Death