MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1457Q/86

Device Problems Therapy Delivered to Incorrect Body Area (1508); Failure to Advance (2524); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 11/02/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-46372.It was reported that a patient presented in-clinic for an unrelated elective replacement procedure.During the procedure, the new left ventricular (lv) lead being placed was unable to be advanced and insulation damage was alleged on the lv lead by the physician.A new lv lead was used to complete the procedure, but this new lv lead was found to be difficult to advance as well.Following the procedure completion, the new lv lead was found to have dislodged, resulting in extra cardiac stimulation and high capture thresholds.Surgical intervention was scheduled but was not yet completed.The patient was stable throughout.

Event Description

Additional information received notes that the left ventricular lead was explanted on (b)(6) 2022 and was not replaced.The patient was stable throughout.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• 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: 15848532
• MDR Text Key: 306828897
• Report Number: 2017865-2022-46377
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• 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: 01/15/2023

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: 09/30/2023
• Device Model Number: 1457Q/86
• Device Catalogue Number: 1457Q/86
• Device Lot Number: A000101808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/27/2022
• Supplement Dates FDA Received: 01/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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: ASSURITY MRI; TENDRILLEADS; TENDRILLEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male