MAUDE Adverse Event Report: ABBOTT CURRENT PLUS VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1211-36
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 2017865-2021-09572.During an in clinic follow-up, the device was found to be in back-up vvi mode.It was also noted that oversensing and decreased pacing impedance were observed on the right ventricular (rv) lead.Insulation damage was suspected but was not confirmed.Technical support was contacted and a firmware download was performed to resolve the back-up vvi.It was suspected that the oversensing on the rv lead may have contributed to the back-up vvi mode on the device.The defibrillation therapy was disabled as an interim resolution and an rv lead replacement procedure and device exchange is anticipated.The patient was stable and will continue to be monitored.
Event or Problem Description
Additional information was received indicating that during the lead revision procedure, the device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
The reported event of backup vvi was confirmed by the field device image, however could not be reproduced in the lab.Interrogation of the device revealed the device was below end of service when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Pacing, sensing, impedance, hv output, patient notifier was tested and no anomaly was detected.The cause of the field event is a hybrid anomaly.

• Brand Name: CURRENT PLUS VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11387015
• Report Number: 2017865-2021-09573
• Device Sequence Number: 4568556
• Product Code: NVZ
• UDI-Device Identifier: 05414734503686
• UDI-Public: 05414734503686
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/25/2021

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: 07/31/2013
• Device Model Number: CD1211-36
• Device Catalogue Number: CD1211-36
• Device Lot Number: 3593197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/03/2021; 04/16/2021; 05/25/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/10/2021; 04/30/2021; 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIATA PASSIVE FIXATION