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

Model Number	CD1211-36
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that device delivered inadequate anti-tachycardia pacing (atp) during an episode of ventricular tachycardia, which accelerated to ventricular fibrillation (vf) following the atp.The device delivered an appropriate shock to terminate the vf episode.Abbott technical support was contacted and recommended reprogramming the device to more accurately diagnose arrhythmias, which was anticipated to resolve the event.The patient was stable and there were no adverse consequences.

• 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: 11711755
• Report Number: 2017865-2021-15798
• Device Sequence Number: 4219803
• 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: 2016
• 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): 04/22/2021

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: 01/31/2018
• Device Model Number: CD1211-36
• Device Catalogue Number: CD1211-36
• Device Lot Number: S000021932
• 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: 04/08/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1