MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER

Model Number 3650

Device Problems Incorrect Measurement (1383); No Apparent Adverse Event (3189)

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

Event Date 03/13/2022

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer report number 2017865-2023-20890.It was reported that the programmer exhibited an incorrect longevity estimate because of a battery longevity calculation overestimation.It is unknown if the programmer was running the updated software version at the time the longevity discrepancy was discovered.The patient¿s pulse generator was explanted, however, it is unknown if the device had reached elective replacement indicator (eri) level.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Further information was requested but not received.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

Additional information was received indicating that during a follow up in clinic in (b)(6)2022, the device was found with battery voltage at elective replacement indicator (eri) level.At the previous interrogation, in (b)(6) 2022, the longevity estimation on the battery was 9.2 months.Longevity overestimation was suspected to have occurred due to the programmer at the previous follow up in clinic.The device was explanted and replaced after reaching eri level due to normal battery depletion.The patient was in stable condition.

Manufacturer Narrative

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

Additional information was received indicating at the time the the longevity discrepancy was observed, the battery longevity estimation was received via a remote transmission from merlin.Net.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: MERLIN PROGRAMMER
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16992012
• MDR Text Key: 315837183
• Report Number: 2017865-2023-20889
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q222-CRM1
• Patient Sequence Number: 1