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

Model Number 3650

Device Problems Failure to Interrogate (1332); Application Program Freezes, Becomes Nonfunctional (4031); Program or Algorithm Execution Failure (4036)

Patient Problem Arrhythmia (1721)

Event Date 07/26/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-17140; related manufacturer reference number: 2017865-2022-17142.It was reported a patient presented with noise on their atrial lead.This was addressed by a procedure on (b)(6) 2022 where the atrial lead was explanted and replaced.During procedure, it was noted that the right ventricular (rv) lead had silicone damage so the rv lead was explanted and replaced as well.Post-procedure, during capture threshold testing, the user released the button on the merlin programmer to terminate the testing as expected.However, the device continued to decrement, resulting in loss of capture, application program freeze, and no telemetry.The patient experienced cardiac arrest, which was resolved by cardiac massage.After this episode, the patient was stable.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

Manufacturer Narrative

Correction: related manufacturer reference number in b5.

Event Description

Related manufacturer reference number: 2017865-2022-17140 related manufacturer reference number: 2017865-2022-17146 it was reported a patient presented with noise on their atrial lead.This was addressed by a procedure on (b)(6) 2022 where the atrial lead was explanted and replaced.During procedure, it was noted that the right ventricular (rv) lead had silicone damage so the rv lead was explanted and replaced as well.Post-procedure, during capture threshold testing, the user released the button on the merlin programmer to terminate the testing as expected.However, the device continued to decrement, resulting in loss of capture, application program freeze, and no telemetry.The patient experienced cardiac arrest, which was resolved by cardiac massage.After this episode, the patient was stable.

Manufacturer Narrative

The reported event of the merlin programmer freezing during use was not able to be confirmed.The results of the software analysis are inconclusive since no additional information was obtained to investigate.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 15192527
• MDR Text Key: 297527344
• Report Number: 2017865-2022-17138
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2011
• 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
• Treatment: PM2172 ENDURITY MRI_PACEMAKER
• Patient Outcome(s): Other