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

Model Number	EX3100
Medical Device Problem Codes	Connection Problem (2900); No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in the clinic for an implant.During the procedure, the pacing system analyzer (psa) unexpectedly disconnected and was unable to provide pacing support.The psa was replaced and the implant procedure was successful.The patient was stable throughout.
Additional Manufacturer Narrative
The reported event of the pacing system analyzer (psa) unexpectedly disconnected and unable to provide pacing support could not be verified.Final analysis found that, the psa was plugged into a testing merlin and powered on successfully.The test performed on the psa revealed that all the resistors (atrium, left ventricle, and right ventricle) were within the impedance levels.No anomalies were found.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14484544
• Report Number: 2017865-2022-10817
• Device Sequence Number: 14742626
• Product Code: NIK
• UDI-Device Identifier: 05414734503105
• UDI-Public: 05414734503105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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?: 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: 05/02/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 1458Q/92 QUARTETLEADS; 2088TC/52 TENDRIL; LDA210Q/65 OPTISUREMRI
• Patient Age: 60 YR
• Patient Sex: Male