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

Model Number	CD1211-36
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow-up, the patient received inappropriate high voltage defibrillation therapy due to the device programming.Abbott technical support was contacted and suggested reprogramming the device to resolve the event.The physician alleged no malfunction on the device and attributed the event to how the device was programmed and the patient needing a dual chamber device instead of only a single chamber.No intervention has been performed at this time.The patient was in stable condition.
Event or Problem Description
Additional information received indicated the event was resolved by explanting and upgrading the patient's replacement device to a dual chamber device and implanting a right atrial lead.The patient was in stable condition.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 11893619
• Report Number: 2017865-2021-19771
• Device Sequence Number: 19754228
• Product Code: NVZ
• UDI-Device Identifier: 05414734503686
• UDI-Public: 05414734503686
• 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: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: CD1211-36
• Device Catalogue Number: CD1211-36
• Device Lot Number: 3917744
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 06/25/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/24/2021; 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention