MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/75

Device Problems Therapy Delivered to Incorrect Body Area (1508); Capturing Problem (2891)

Patient Problem Discomfort (2330)

Event Date 08/11/2023

Event Type  Injury  

Event Description

Related mfr report number: 2017865-2023-40765.Related mfr report number: 2017865-2023-50507.It was reported that a patient presented to clinic for right ventricular (rv) lead revision due to high defibrillation impedance and suspected rv lead fracture.Device interrogation revealed oversensing noise on the atrial lead and high capture threshold and extra cardiac stimulation on the left ventricular (lv) lead.The physician elected to explant and replace the rv, atrial, and lv leads.The patient condition was stable before, during, and after the procedure.

Manufacturer Narrative

The reported events of extra muscle stimulation and inadequate capture were confirmed.Visual examination found one external insulation abrasion consistent with friction to another device or feature of patient¿s anatomy.The cause of the reported events was isolated to the exposed inner coil at the abrasion region.Electrical testing did not find any indication of conductor fractures or internal shorts.All other damage found is consistent with procedural damage.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• 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: 17996825
• MDR Text Key: 326396003
• Report Number: 2017865-2023-50508
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: 05414734503334
• 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
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 1458Q/75
• Device Lot Number: 4007135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2013
• 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
• Treatment: QUADRA ASSURA ICD
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female