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

Model Number 1458Q/75

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

Patient Problems Pain (1994); Swelling (2091); Thrombosis (2100); Discomfort (2330)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient developed a deep vein thrombosis and presented to the hospital on (b)(6) 2020.The thrombosis was stated to be a known risk of the pulse generator system implant procedure that was completed on (b)(6) 2020 due to lead insertion into the vein.The patient reported upper extremity swelling and pain.A duplex testing was performed and it was recommended that the patient treat the swelling with compression, elevation, anti-coagulation, and activity restrictions.The patient was prescribed medication and at pre-discharge check on (b)(6), was progressing back to baseline.The patient presented again on (b)(6) 2020 for a follow up and was noted to have soreness around the implant site.The condition was reported to be getting better everyday.The patient was prescribed aspirin to ease the discomfort at night.Related manufacturer reference number: 2017865-2020-06631, 2017865-2020-06632.

• 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
• MDR Report Key: 10092751
• MDR Text Key: 192208501
• Report Number: 2017865-2020-06633
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: 05414734503334
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 1458Q/75
• Device Catalogue Number: 1458Q-75
• Device Lot Number: A000091218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2019
• 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
• Treatment: DURATA; TENDRIL STS
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 77