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	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the programmer exhibited an incorrect longevity estimate because of a battery longevity calculation overestimation.The patient¿s pulse generator was explanted prior to reaching its elective replacement indicator (eri).No patient complications have been reported as a result of this event.Related manufacturer reference number: 2017865-2022-22610.

• 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: 15374389
• Report Number: 2017865-2022-22611
• Device Sequence Number: 5674174
• Product Code: OSR
• UDI-Device Identifier: 05415067031174
• UDI-Public: 05415067031174
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown