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

Model Number	CD2211-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the device reached its elective replacement indicator (eri) prematurely.Device replacement was anticipated.The patient was stable and there were no adverse consequences.
Event or Problem Description
It was reported that the device was explanted and replaced.The patient was stable following the procedure and there were no adverse consequences.
Additional Manufacturer Narrative
Premature battery depletion was confirmed from the analysis of the current plus device.The device was received with battery voltage at end of service (eos) level.During functional testing, high current drain was detected and isolated to an integrated circuit (ic) anomaly in the electronic circuit board of the device.High current drain caused the battery to deplete earlier than expected.

• Brand Name: CURRENT+ DR DUAL-CHAMBER ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9082717
• Report Number: 2938836-2019-13720
• Device Sequence Number: 2883194
• Product Code: NVZ
• UDI-Device Identifier: 05414734503723
• UDI-Public: 05414734503723
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2020

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: 06/30/2016
• Device Model Number: CD2211-36
• Device Catalogue Number: CD2211-36
• Device Lot Number: S000000335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 04/23/2020
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/03/2019; 05/12/2020
• 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: Hospitalization; Required Intervention