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

Model Number EX3100

Device Problems Connection Problem (2900); No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 292478054
• Report Number: 2017865-2022-10817
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503105
• UDI-Public: 05414734503105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1458Q/92 QUARTETLEADS; 2088TC/52 TENDRIL; LDA210Q/65 OPTISUREMRI
• Patient Age: 60 YR
• Patient Sex: Male