MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT PLUS VR, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1211-36Q
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced ventricular tachycardia (vt) and was admitted to the hospital.The patient received external defibrillation to resolve the vt.Device interrogation revealed that the implantable cardioverter defibrillator was in backup vvi.The device was explanted and replaced due to battery exhaustion.The patient was stable post procedure.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed.Analysis of device image found the device went into backup mode due to excessive charges resulting in a power on reset (por).After the device was restored from backup mode, functional testing was performed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.A longevity calculation was performed and found the battery depletion was normal based on the device usage.

• Brand Name: CURRENT PLUS VR, DF-4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14136838
• Report Number: 2017865-2022-08185
• Device Sequence Number: 17703809
• Product Code: NVZ
• UDI-Device Identifier: 05414734503716
• UDI-Public: 05414734503716
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 02/29/2020
• Device Model Number: CD1211-36Q
• Device Catalogue Number: CD1211-36Q
• Device Lot Number: S000063585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown