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

Model Number	1458QL/75
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer number: 2017865-2022-02579.Related manufacturer number: 2017865-2022-02580.It was reported that the patient's right atrial lead exhibited noise.During the lead replacement procedure, the right ventricular and left ventricular leads dislodged.The right atrial lead was removed and replaced.The right ventricular lead and left ventricular lead were removed and reimplanted on (b)(6) 2022.The patient was discharged.
Event or Problem Description
Related manufacturer number: 2017865-2022-02579, related manufacturer number: 2017865-2022-02580.It was reported that the patient's right atrial lead exhibited noise.During the lead replacement procedure, the right ventricular and left ventricular leads dislodged.The leads were removed and replaced.The patient was discharged.
Additional Manufacturer Narrative
Correction: b5 updated to mention lead explant and replacement.D6b should be (b)(6) 2022.

• Brand Name: QUARTET
• 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: 13447175
• Report Number: 2017865-2022-02581
• Device Sequence Number: 20199249
• Product Code: NIK
• UDI-Device Identifier: 05414734510202
• UDI-Public: 05414734510202
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 1458QL/75
• Device Catalogue Number: 1458QL/75
• Device Lot Number: A000039407
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• 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: QUADRA ALLURE MP PACER
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG