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 Dizziness (2194)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

It was reported the patient presented in clinic for follow-up.A threshold test was performed.After one beat of non-capture occurred, the test was cancelled and there was a five second delay before returning to normal programming.The threshold test was attempted a second time on a second vector.After one beat of non-capture occurred, the test continued to decrement and waited approximately five seconds before returning to normal programming.The patient reported feeling dizzy during the threshold testing and was asymptomatic before and after the testing.

Manufacturer Narrative

The reported event of a delay in cancellation of the threshold decrement test was unable to be confirmed.The additional information provided was reviewed by abbott engineering and the test was aborted within 2 seconds of cancellation.

• 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: 14466007
• MDR Text Key: 292387616
• Report Number: 2017865-2022-10642
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• 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
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GALLANT HF; OPTISURE MRI; QUARTET; TENDRIL STS
• Patient Age: 59 YR
• Patient Sex: Female