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

Model Number	CD2211-36Q
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	04/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Patient was presented in clinic after receiving inappropriate high voltage (hv) therapy.Upon investigation, the device was found to have reached the elective replacement indicator (eri) due to normal battery depletion and had gone into backup vvi shortly after reaching eri.Technical support was contacted and recommended replacement to address the eri.The patient was stable and will continue to be monitored.
Event or Problem Description
Additional information received indicated the device was explanted and replaced to resolve the event.The patient was in stable condition.

• 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: 9986421
• Report Number: 2938836-2020-02749
• Device Sequence Number: 4442091
• Product Code: NVZ
• UDI-Device Identifier: 05414734503709
• UDI-Public: 05414734503709
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 08/31/2014
• Device Model Number: CD2211-36Q
• Device Catalogue Number: CD2211-36Q
• Device Lot Number: 3974883
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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