MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CURRENT ACCEL VR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1215-36Q
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Therapeutic Effects, Unexpected (2099)
Date of Event	06/14/2018
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 device was interrogated and the capacitor charge time limit was reached.However, since the patient received several shocks and the battery voltage was decreased, the extended charge time was noted to be normal.Several ventricular tachycardia (vt) and ventricular fibrillation (vf) episodes were observed which were caused by atrial fibrillation with high ventricular frequency resulting in inappropriate shocks.In other cases, real vt episodes were recorded and treated appropriately.The vf zone was increased and no further intervention was performed.The patient is hospitalized for other comorbidities.The device was implanted in 2013; however, the exact date is unknown.

• Brand Name: CURRENT ACCEL VR ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7633925
• Report Number: 2938836-2018-08111
• Device Sequence Number: 19287222
• Product Code: NVZ
• UDI-Device Identifier: 05414734503044
• UDI-Public: 05414734503044
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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: 07/31/2011
• Device Model Number: CD1215-36Q
• Device Lot Number: 3070115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/25/2018
• 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: Required Intervention