MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) MERLIN PACING SYSTEM ANALYZER; NO MATCH

Model Number	EX3100
Medical Device Problem Codes	Loose or Intermittent Connection (1371); No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, it was noted the right atrial (ra) lead had dislodged.The dislodgement occurred during stylet removal and was confirmed intraoperatively under fluoroscopy in the catheterization laboratory.After dislodgement, the lead was removed once, and the screw was confirmed to be normal.During a subsequent attempt to re implant in the right atrial appendage, pacing system analyzer (psa) measurements prior to screw fixation could not be performed.Upon connecting the threshold cable, no waveform was obtained, and no pacing output was observed.The ra lead was suspected to be damaged.The ra lead is not used and replaced.The psa was not used.The patient was in stable condition throughout the procedure.

• Brand Name: MERLIN PACING SYSTEM ANALYZER
• 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: 25344454
• Report Number: 2017865-2026-11258
• Device Sequence Number: 12038487
• Product Code: NIK
• UDI-Device Identifier: 05414734503105
• UDI-Public: (01)05414734503105(10)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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 Model Number: EX3100
• 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: 05/15/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 05/31/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown