MAUDE Adverse Event Report: ABBOTT CURRENT PLUS VR, DF-4 CONNECTOR; Pulse generator, permanent, implantable

Model Number	CD1211-36Q
Medical Device Problem Codes	Over-Sensing (1438); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a clinic follow-up, episodes of post-sensed t wave oversensing and r wave amplitude variation were observed on the device.Technical support was contacted and the device was reprogrammed to resolve the event.The patient was stable and will continue to be monitored.

• Brand Name: CURRENT PLUS VR, DF-4 CONNECTOR
• 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: 17773632
• Report Number: 2017865-2023-46455
• Device Sequence Number: 6114412
• Product Code: NVZ
• UDI-Device Identifier: 05414734503716
• UDI-Public: 05414734503716
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/19/2023

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 Expiration Date: 06/30/2017
• Device Model Number: CD1211-36Q
• Device Lot Number: S000014851
• 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: 09/04/2023
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2015
• 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