MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; No Match

Model Number 3650

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

The longevity estimation anomaly near elective replacement indicator (eri) was confirmed by reviewing the data in the device image and session records.The longevity overestimation was determined to be due to an estimation inaccuracy in the merlin programmer remaining longevity calculation.This report is being submitted for the programmer as a part of the programmer longevity estimator software error field action(fda recall number: fa-q222-crm1) set of complaints.Should any additional information be obtained, a supplemental report will be issued.

Event Description

Related manufacturer report number: 2017865-2022-51057.This report is to advise of an event observed during analysis.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: No Match
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17830568
• MDR Text Key: 324459444
• Report Number: 2017865-2023-47117
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FA-Q222-CRM1
• Patient Sequence Number: 1