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

Model Number	1458QL/75
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: 2017865-2022-47524.It was reported a patient presented with diaphragmatic stimulation on the left ventricular lead.Upon further analysis in clinic, the implantable cardioverter defibrillator (icd) presented in backup vvi mode.Programming changes were made to address both anomalies.The patient was stable.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15906548
• Report Number: 2017865-2022-47527
• Device Sequence Number: 20124272
• Product Code: NIK
• UDI-Device Identifier: 05414734510202
• UDI-Public: 05414734510202
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/02/2022

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: 04/30/2024
• Device Model Number: 1458QL/75
• Device Catalogue Number: 1458QL/75
• Device Lot Number: A000109393
• 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: 11/20/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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: 2088TC/46 TENDRIL; 2088TC/58 TENDRILLEAD
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White