MAUDE Adverse Event Report: ABBOTT CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2211-36Q
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device failed to treat an episode of ventricular fibrillation due to a high defibrillation threshold.Abbott technical support was contacted and recommended reprogramming, which was performed to resolve the event.The patient was stable and there were no adverse consequences.

• Brand Name: CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9306855
• Report Number: 2938836-2019-16125
• Device Sequence Number: 2030264
• Product Code: NVZ
• UDI-Device Identifier: 05414734503709
• UDI-Public: 05414734503709
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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: 03/31/2014
• Device Model Number: CD2211-36Q
• Device Lot Number: 3819304
• 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: 10/28/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1