MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number	1458Q/75
Medical Device Problem Codes	Break (1069); Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the right ventricular (rv) lead exhibited high defibrillation impedance.No intervention was reported.The patient condition was unknown.New information received notes that the high defibrillation impedance was noted in clinic.Imaging was performed.The patient was in stable condition.New information received notes that the patient presented for an explant procedure.During the procedure, while attempting to explant the right ventricular (rv) lead, it was noted that the rv lead broke.It was then noted that the left ventricular (lv) lead was harmed in the process of extracting the rv lead.The lv lead was attempted to be extracted and broke.The rv and lv leads were capped and replaced on (b)(6) 2026.The patient was in stable condition.
Additional Manufacturer Narrative
B5 should include that the left ventricular (lv) lead exhibited high capture thresholds and failure to capture in initial report.
Event or Problem Description
It was reported that the right ventricular (rv) lead exhibited high defibrillation impedance.No intervention was reported.The patient condition was unknown.New information received notes that the high defibrillation impedance was noted in clinic.Imaging was performed.The patient was in stable condition.New information received notes that the patient presented for an explant procedure.During the procedure, while attempting to explant the right ventricular (rv) lead, it was noted that the rv lead broke.Upon review, it was noted that the lv lead exhibited high capture thresholds and failure to capture.It was then noted that the left ventricular (lv) lead was harmed in the process of extracting the rv lead.The lv lead was attempted to be extracted and broke.The rv and lv leads were capped and replaced on (b)(6) 2026.The patient was in stable condition.

• Brand Name: QUARTET
• Common Device Name: NO MATCH
• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24501127
• Report Number: 2017865-2026-04413
• Device Sequence Number: 18670810
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: (01)05414734503334(10)A000033103(17)191130
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 11/30/2019
• Device Model Number: 1458Q/75
• Device Lot Number: A000033103
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2016
• 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: QUADRA.; TENDRIL.
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 92 KG