MAUDE Adverse Event Report: ABBOTT MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number	MER3700
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the programmer exhibited an incorrect longevity estimate because of a battery longevity calculation overestimation.No patient complications have been reported as a result of this event.
Additional 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.
Additional 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.

• Brand Name: MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER
• Common Device Name: 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15008298
• Report Number: 2017865-2022-14818
• Device Sequence Number: 11342066
• Product Code: OSR
• UDI-Device Identifier: 05415067031174
• UDI-Public: 05415067031174
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MER3700
• Device Catalogue Number: MER3700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q222-CRM1¿
• Patient Sequence Number: 1
• Patient Sex: Unknown