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	Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for lead revision.The left ventricular (lv) lead showed loss of capture and there was phrenic nerve stimulation.The lv lead was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported events of failure to capture and extra cardiac stimulation were no confirmed.As received, a complete lead was returned in one piece for analysis.Visual and x-ray inspections of the lead did not find any anomalies.Electrical testing did not find any indication of conductor fractures or internal shorts.No anomalies were found.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14106611
• Report Number: 2017865-2022-07907
• Device Sequence Number: 4805311
• Product Code: NIK
• UDI-Device Identifier: 05414734510141
• UDI-Public: 05414734510141
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/14/2023

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: 07/31/2024
• Device Model Number: 1456Q/75
• Device Catalogue Number: 1456Q/75
• Device Lot Number: A000113288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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: GALLANT.; OPTISURE.; TENDRIL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male