MAUDE Adverse Event Report: ABBOTT AVEIR¿ PROGRAMMER LINK MODULE; LEADLESS PACEMAKER

Model Number	LSL02
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the electrocardiogram (ecg) transmitted by the programmer link did not display the loss of capture that occurred during a capture threshold test.The patient is pacer-dependent and subsequently, the patient experienced dizziness.The physician performed the test again with an external ecg cable and successfully identified when loss of capture occurred.No additional intervention was performed to resolve the event and the patient was in stable condition.

• Brand Name: AVEIR¿ PROGRAMMER LINK MODULE
• Common Device Name: LEADLESS 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: 18241210
• Report Number: 2017865-2023-93242
• Device Sequence Number: 3227409
• Product Code: PNJ
• UDI-Device Identifier: 05415067031914
• UDI-Public: 05415067031914
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150035
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: LSL02
• Device Lot Number: WMP125837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/19/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown