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

Model Number	1258T/75
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Discomfort (2330); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow-up in clinic.It was noted that the left ventricular lead failed to capture and exhibited high pacing impedance.Programming changes were made.The patient stable.
Event or Problem Description
New information received which notes a suspected fracture, fluoroscopy was performed, no anomalies were seen, no other symptoms other than phrenic nerve stimulation, fracture was suspected due to extremely high pacing impedance.The lead was explanted on (b)(6) 2024.The left ventricular (lv) lead broke off in process, dislodging and was found floating in right ventricle.Attempts to snare the (lv) lead were performed until maximum radiation levels.
Event or Problem Description
New information received notes the patient was sent to a separate facility and the remaining half of the left ventricular (lv) lead was removed on (b)(6) 2025.The patient was stable following the procedure.
Additional Manufacturer Narrative
G3 correction: the g3 of the previous report should have been jan 21, 2025, instead of jan 23, 2025.¿.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Common Device Name: 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: 16641741
• Report Number: 2017865-2023-16241
• Device Sequence Number: 14982571
• Product Code: OJX
• UDI-Device Identifier: 05414734502603
• UDI-Public: 05414734502603
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: 1258T/75
• Device Catalogue Number: 1258T-75
• Device Lot Number: 3399246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 12/04/2024; 01/23/2025; 02/19/2025
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 12/27/2024; 02/07/2025; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLURE RF; TENDRIL ACTIVE; TENDRIL ACTIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male