MAUDE Adverse Event Report: ABBOTT CURRENT PLUS VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1211-36
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a remote follow-up, post-sensed t-wave oversensing was observed on the device.Abbott technical support was contacted and the device was reprogrammed to resolve the event.The patient was in stable condition.

• Brand Name: CURRENT PLUS VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12525721
• Report Number: 2017865-2021-31305
• Device Sequence Number: 19906241
• Product Code: NVZ
• UDI-Device Identifier: 05414734503686
• UDI-Public: 05414734503686
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 05/31/2017
• Device Model Number: CD1211-36
• Device Catalogue Number: CD1211-36
• Device Lot Number: S000013631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1