MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX LV LEAD; Drug eluting permanent left ventricular (lv) pacemaker electrode

Model Number 1156T/86

Device Problem Signal Artifact/Noise (1036)

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Manufacturer Narrative

Udi not available as product was manufactured on or before 23 sep 2014.Further information was requested but not received.

Event Description

Related manufacturer reference number: 2017865-2024-01498.It was reported the patient presented with syncope and an implantable cardioverter defibrillator (icd) that exhibited an unspecified malfunction.The left ventricular lead exhibited noise.The implantable cardioverter defibrillator (icd) was explanted and replaced, and the left ventricular lead was capped and replaced on (b)(6) 2023.The patient condition was unknown.

• Brand Name: QUICKFLEX LV LEAD
• Type of Device: Drug eluting permanent left ventricular (lv) 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: 18560054
• MDR Text Key: 333433924
• Report Number: 2017865-2024-01499
• Device Sequence Number: 1
• Product Code: OJX
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: 1156T/86
• Device Lot Number: 2776565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2009
• 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): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 60 KG