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

Model Number CD1275-36

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/21/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 317828909
• Report Number: 2017865-2023-23661
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734506021
• UDI-Public: 05414734506021
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1