MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 75 CM; PERMANENT PACEMAKER ELECTRODE

Model Number	1457Q/75
Medical Device Problem Codes	Capturing Problem (2891); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in-patient in hospital.During interrogation, it was noted that the left ventricular lead was found dislodged and causing failure to capture.The reported lead was explanted and replaced on (b)(6) 2022 during a generator changeout procedure.The patient was in stable condition.
Event or Problem Description
It was reported that the patient presented in-patient in hospital.During interrogation, it was noted that the left ventricular lead was found dislodged and causing failure to capture.The reported lead was explanted and replaced on (b)(6) 2022 during a generator changeout procedure.The patient was in stable condition.

• Brand Name: QUARTET LEAD DOUBLE BEND, 75 CM
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13599102
• Report Number: 2017865-2022-04072
• Device Sequence Number: 14886149
• Product Code: OJX
• UDI-Device Identifier: 05414734510172
• UDI-Public: 05414734510172
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 09/30/2024
• Device Model Number: 1457Q/75
• Device Catalogue Number: 1457Q/75
• Device Lot Number: A000116264
• 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: 02/18/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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: DURATA TACHY MRI; GALLANT HF; TENDRIL LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male