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

Model Number 1458Q/86

Device Problems Fracture (1260); High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

The left ventricular (lv) lead exhibited high pacing impedance.No intervention was performed and the patient status was unknown.

Event Description

New information received notes that the lead was fractured.The lead was capped on (b)(6) 2023.The patient condition was stable.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15883278
• MDR Text Key: 306786816
• Report Number: 2017865-2022-47105
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000027591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2016
• 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 ACTIVE LEAD; QUADRA ASSURA MP ICD; RIGHT ATRIAL LEAD
• Patient Outcome(s): Required Intervention
• Patient Sex: Male