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

Model Number	1456Q/75
Medical Device Problem Codes	Intermittent Capture (1080); Capturing Problem (2891)
Health Effect - Clinical Codes	Discomfort (2330); Syncope/Fainting (4411)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested, but not received.
Event or Problem Description
Related manufacturer reference number: 2017865-2022-12804; related manufacturer reference number: 2017865-2022-12805.It was reported that a patient presented to the emergency room reporting falls and syncopial episodes.Upon examination, the patient¿s right ventricular (rv) and left ventricular (lv) lead were found to have intermittent loss of capture.The loss of capture was alleged on the patient¿s pacemaker.The rv and lv leads were found to also have high capture thresholds.Corrective programming changes were made.The patient was stable throughout.
Event or Problem Description
New information received notes that intermittent capture was alleged on the right ventricular (rv) and left ventricular (lv) leads.The event occurred on (b)(6) 2022.

• Brand Name: QUARTET LEAD SMALL-S, 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: 14738268
• Report Number: 2017865-2022-12807
• Device Sequence Number: 19389838
• Product Code: NIK
• UDI-Device Identifier: 05414734510141
• UDI-Public: 05414734510141
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/12/2022

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: 1456Q/75
• Device Catalogue Number: 1456Q/75
• Device Lot Number: A000116341
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG