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	Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2022-17451.It was reported that the patient presented in clinic for follow up.Upon review, the left ventricular lead exhibited loss of capture.The patient presented to a scheduled lead revision procedure.During the procedure, it was noted that the lv lead was dislodged and that the right ventricular(rv) lead exhibited decreased r-waves.The rv lead could not be re-positioned as the helix would not retract nor extend.The rv and lv leads were explanted and replaced.There were no patient consequences.
Additional Manufacturer Narrative
The reported events were lead dislodgement and loss of capture.As received, a complete lead was returned in one piece for analysis.The reported event of loss of capture was not confirmed.Electrical testing and x-ray examination did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for procedural damage.The double bend height measured with in 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: 15218132
• Report Number: 2017865-2022-17450
• Device Sequence Number: 12215210
• Product Code: OJX
• UDI-Device Identifier: 05414734510172
• UDI-Public: 05414734510172
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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: 10/31/2024
• Device Model Number: 1457Q/75
• Device Catalogue Number: 1457Q/75
• Device Lot Number: A000117637
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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: GALLANT; TENDRIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 98 KG