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

Model Number	EX3100
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
Related manufacturer reference number: 2017865-2022-37749.It was reported that the patient presented for a scheduled procedure.During the procedure, it was noted that the merlin pacing system analyzers (psa) was failing to provide temporary pacing support and failing to measure sensing, impedance and capture.The psa was not used and replaced with second psa, it was failing to provide temporary pacing support and failing to give the measurements as well.The physician continue to use third psa and completed the procedure.The patient was in stable condition.
Additional Manufacturer Narrative
Correction: the correct occupation should have been physician, rather than other healthcare professional.

• 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: 15399589
• Report Number: 2017865-2022-37748
• Device Sequence Number: 6463997
• 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,Followup
• Report Date (Section B): 10/17/2022

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?: 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: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 10/17/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 09/13/2022; 10/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown