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	08/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow-up, the device was found to have reached its elective replacement indicator (eri).Premature battery depletion was suspected and was confirmed during review of device images by abbott technical support.The device was explanted and replaced to resolve the event.The patient was stable following the procedure and there were no adverse consequences.
Additional Manufacturer Narrative
As received the device was end of service (eos) battery level.A longevity calculation was performed and the device did not meet its expected longevity requirements.The original battery was replaced; functional testing with a new battery was normal.The original battery was sent to the manufacturer for additional analysis but the cause of the premature battery depletion could not be conclusively determined.As a result of this finding, abbott is performing further investigation.

• 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: 8920851
• Report Number: 2938836-2019-12687
• Device Sequence Number: 2230025
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 08/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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