MAUDE Adverse Event Report: ABBOTT ELLIPSE VR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD1275-36
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During remote follow-up, an egm was observed to be missing after the device delivered appropriate high voltage therapy.No intervention was performed.The patient was stable and will continue to be monitored.There were no adverse consequences.

• Brand Name: ELLIPSE VR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 17164389
• Report Number: 2017865-2023-23661
• Device Sequence Number: 20288160
• Product Code: NVZ
• UDI-Device Identifier: 05414734506021
• UDI-Public: 05414734506021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup
• Report Date (Section B): 08/23/2024

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
• Device Expiration Date: 06/30/2018
• Device Model Number: CD1275-36
• Device Catalogue Number: CD1275-36
• Device Lot Number: S000028057
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 09/21/2023; 08/20/2024
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 09/21/2023; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• 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
• Patient Sex: Unknown