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

Model Number 1156T/86

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Discomfort (2330)

Event Date 03/30/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-17741 / 2017865-2023-17743.It was reported that the patient's right ventricular high voltage lead delivered an inappropriate shock.The shock was due to over-sensed noise from the right ventricular sensing lead.High capture threshold was also noted.The patient presented for a lead revision.Prior to the procedure, the patient had experienced diaphragmatic stimulation from the left ventricular lead.The leads were explanted and replaced.The patient condition was stable.

• Brand Name: QUICKFLEX LV LEAD
• 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: 16753354
• MDR Text Key: 313430308
• Report Number: 2017865-2023-17747
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00541473450202
• UDI-Public: 0541473450202
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: 1156T/86
• Device Lot Number: 0002662234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2008
• 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: FORTIFY ASSURA
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male