MAUDE Adverse Event Report: ABBOTT CURRENT ACCEL VR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1215-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
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
The patient received a vibratory alert and presented in clinic for a follow up.Premature battery depletion was suspected.No intervention has been performed, device explant and replacement is anticipated.The patient was in stable condition.
Event or Problem Description
Additional information was received indicating the device was explanted and replaced to resolve the event.
Additional Manufacturer Narrative
The reported event of premature battery depletion was not confirmed.In-lab assessment and testing showed normal device function and a longevity estimate showed normal battery depletion.

• Brand Name: CURRENT ACCEL VR, 36J
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8804768
• Report Number: 2938836-2019-06079
• Device Sequence Number: 10848379
• Product Code: NVZ
• UDI-Device Identifier: 05414734502634
• UDI-Public: 05414734502634
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 03/27/2020

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: 04/30/2011
• Device Model Number: CD1215-36
• Device Catalogue Number: CD1215-36
• Device Lot Number: 2922753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 03/20/2020
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/21/2019; 03/27/2020
• 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