MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) QUARTET; NO MATCH

Model Number	1458Q/86
Medical Device Problem Codes	Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital for an implant procedure on (b)(6) 2026.It was found that the left ventricular (lv) lead was dislodged, which was confirmed by chest x-ray and resulting in loss of capture.Upon repositioning of the lv lead, the lv lead could not be placed securely due to the patient¿s anatomy.Consequently, the lv lead was replaced on (b)(6) 2026.The patient was in stable condition.
Additional Manufacturer Narrative
The reported events were lead dislodgement and failure to capture.A complete lead was returned in one piece.No lead anomalies were found.The s-curve hump height was measured to be within product specification.The reported event of failure to capture was not confirmed.Final analysis found no indication of conductor fractures or internal shorts.

• Brand Name: QUARTET
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24738891
• Report Number: 2017865-2026-06575
• Device Sequence Number: 19963205
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: (01)05414734503198(10)A000183111(17)281231
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/07/2026

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 Model Number: 1458Q/86
• Device Lot Number: A000183111
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2026
• 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 TACHY MRI LEAD.; GALLANT HF ICD.; ULTIPACE LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male