MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 3650

Device Problem Program or Algorithm Execution Failure (4036)

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

Event Date 12/21/2020

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for a system implant procedure.During capture threshold testing post-implant, it was found that as the user released the button to terminate the testing as expected, the device continued to decrement, resulting in a loss of capture.The test was manually terminated.The patient was stable.

Manufacturer Narrative

Correction: d4: udi number should have been (b)(4) rather than left blank.

Manufacturer Narrative

The reported event of loss of capture during threshold testing was confirmed.Analysis of the device diagnostics found that the issue most likely occurred due to algorithm execution failure.No other anomalies were found.

Event Description

It was reported the device was subject to the decrement test field action issued by abbott on (b)(6) 2022.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 11324891
• MDR Text Key: 231729277
• Report Number: 2017865-2021-08625
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2022

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
• Device Operator: Health Professional
• Device Model Number: 3650
• Device Catalogue Number: 3650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/12/2021; 06/02/2021; 03/10/2022
• Supplement Dates FDA Received: 02/12/2021; 06/02/2021; 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2017865-03/10/22¿001¿C¿
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White