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

Model Number 3650

Device Problems Program or Algorithm Execution Problem (4033); Program or Algorithm Execution Failure (4036)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.

Event Description

During capture threshold testing, the user released the button on the programmer to terminate the testing as expected, however, the implantable cardioverter defibrillator continued to decrement.The programmer was shut off prior to loss of capture for the dependent patient.The patient was in stable condition.

Manufacturer Narrative

The reported event of loss of capture during threshold testing was confirmed.The cause of the event was attributed to the programmer's failure to execute the algorithm to terminate testing.No other anomalies were found.

Event Description

Decrement test field action issued by abbott on 10 march 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: 11597046
• MDR Text Key: 243201421
• Report Number: 2017865-2021-13398
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/05/2021; 06/29/2021; 09/24/2021; 03/10/2022
• Supplement Dates FDA Received: 04/12/2021; 06/29/2021; 09/24/2021; 04/07/2022
• 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
• Removal/Correction Number: 2017865-03/10/22¿001¿C
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White