MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PACING SYSTEM ANALYZER; ACCESSORY

Model Number	EX3100
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the pacing system analyzer (psa) that was connected to the patient exhibited no low voltage output and failed to do the measurement.The test continued with other method with a good measurement result.The patient was stable throughout the procedure.

• Brand Name: MERLIN PACING SYSTEM ANALYZER
• Common Device Name: ACCESSORY
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15859521
• Report Number: 2017865-2022-46600
• Device Sequence Number: 5845790
• Product Code: NIK
• UDI-Device Identifier: 05414734503105
• UDI-Public: 05414734503105
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/02/2023

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
• Device Catalogue 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: 11/04/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Sex: Unknown