MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; No Match

Model Number 1456Q/86

Device Problems Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for a left ventricular (lv) lead revision procedure.It was noted that the lv lead became dislodged due to fall causing loss of capture.Muscle stimulation was also noted causing the patient discomfort.A chest x-ray confirmed the lv lead was dislodged.The physician tried repositioning the lv lead but encountered difficulties and elected to cap and replace the lv lead on (b)(6) 2024 instead.The patient was stable throughout the procedure.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• 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: 18855867
• MDR Text Key: 337102407
• Report Number: 2017865-2024-34325
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 1456Q/86
• Device Lot Number: A000042772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• 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: DURATATACY MRI LEADS; QUADRAASSURA MRI; TENDRILLEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female