MAUDE Adverse Event Report: ABBOTT CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2211-36
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in clinic follow up, it was noted there were episodes of ventricular tachycardia (vt).The device delivered a shock, however, it failed to terminate the arrhythmia.The arrhythmia terminated on its own.Technical support was contacted and recommended reprogramming.No intervention has been performed at this time.The patient was stable and will continue to be monitored.
Event or Problem Description
During an in clinic follow up, it was noted there were episodes of ventricular tachycardia (vt).The device delivered a shock, however, it failed to terminate the arrhythmia.The arrhythmia terminated on its own.Technical support was contacted and recommended reprogramming.No intervention has been performed at this time.The patient was stable and will continue to be monitored.
Event or Problem Description
Additional information was received indicating the device was explanted and replaced to resolve the event.

• Brand Name: CURRENT+ DR DUAL-CHAMBER ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13578230
• Report Number: 2017865-2022-03791
• Device Sequence Number: 14555329
• Product Code: NVZ
• UDI-Device Identifier: 05414734503723
• UDI-Public: 05414734503723
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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 Expiration Date: 05/31/2016
• Device Model Number: CD2211-36
• Device Catalogue Number: CD2211-36
• Device Lot Number: 4894303
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RIGHT VENTRICULAR LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown