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	Break (1069); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: 2017865-2022-07075, related manufacturer reference number: 2017865-2022-07076.It was reported that the patient presented in clinic for follow up.Device interrogation revealed dislodgement on the left ventricular (lv) lead and atrial lead.The physician elected to explant and replace the lv and atrial lead.The replacement lv lead was found to have a loose connector pin and was unable to be implanted.A new lv lead was successfully implanted.The patient condition was stable.
Additional Manufacturer Narrative
The reported events were ¿loose connector pin¿ and lead dislodgement.As received, a complete lead was returned in one piece.The reported event of ¿loose connector pin¿ was not confirmed.Visual examination of the lead did not find any anomalies.Electrical testing did not find any indication of conductor fractures or internal shorts.Double-bend height was measured to be within specification.

• 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: 14005549
• Report Number: 2017865-2022-07077
• Device Sequence Number: 14561101
• Product Code: OJX
• UDI-Device Identifier: 05414734510172
• UDI-Public: 05414734510172
• 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
• 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,Followup
• Report Date (Section B): 05/05/2022

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: 09/30/2023
• Device Model Number: 1457Q/75
• Device Catalogue Number: 1457Q/75
• Device Lot Number: A000102016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022; 04/14/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/14/2022; 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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 RIGHT VENTRICULAR LEAD; QUADRA ASSURA ICD
• Patient Age: 78 YR
• Patient Sex: Female