MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number PROGRAMMER

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer report number 2017865-2023-20884.It was reported that during a follow-up, a decrease in longevity was noted on the device compared to the previous follow-up.A longevity overestimation was suspected to have occurred due to the programmer at the previous interrogation.It is unknown if the programmer was running the updated software version at the time the longevity discrepancy was discovered.The device was explanted, however, it is unknown if the device had reached elective replacement indicator (eri) level.The patient has passed away, however, there is no allegation the death was product-related, nor procedure related and is, therefore, considered unrelated.

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.

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.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 16991862
• MDR Text Key: 315835783
• Report Number: 2017865-2023-20885
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 08/04/2023

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: PROGRAMMER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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