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

Model Number	CD1211-36Q
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Under-Sensing (1661)
Health Effect - Clinical Codes	Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had multiple shocks delivered due to a ventricular tachycardia storm.The patient arrived at the hospital and a magnet was placed over the device and external defibrillation was delivered.Abbott technical support was contacted and undersensing was observed due to device programming.There was no alleged malfunction against the device, the r wave signal was very small at the time of undersensing.The patient also experienced a delay in therapy due to undersensing; however, since the patient had a vt storm, multiple high voltage shocks were delivered in a short amount of time.The patient received an upgraded triple chamber device to resolve the event.

• Brand Name: CURRENT PLUS VR, DF-4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12909232
• Report Number: 2017865-2021-38016
• Device Sequence Number: 4946702
• Product Code: NVZ
• UDI-Device Identifier: 05414734503716
• UDI-Public: 05414734503716
• 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: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: 04/30/2016
• Device Model Number: CD1211-36Q
• Device Catalogue Number: CD1211-36Q
• Device Lot Number: 4881142
• Was Device Available for Evaluation?: No
• 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: 11/18/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2014
• 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