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

Model Number	1207-36
Medical Device Problem Codes	Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	08/19/2019
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
It was reported that patient came into clinic after reportedly being shocked when the device was end of service.It was unknown if the shock was appropriate or not as the electrogram was unavailable due to excessive electrograms taking up storage.Some ventricular tachycardia episodes that were visible were not appropriate.It was decided to turn the device off and not replace it due to patient specific reasons and not due in any way to the device.There was no complaint that this was precipitous depletion.Patient stable.

• Brand Name: CURRENT VR RF
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8949821
• Report Number: 2017865-2019-13129
• Device Sequence Number: 2688211
• Product Code: LWS
• UDI-Device Identifier: 05414734501941
• UDI-Public: 05414734501941
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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: 11/30/2010
• Device Model Number: 1207-36
• Device Lot Number: 3096427
• 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: 08/19/2019
• Initial Report FDA Received Date: 08/30/2019
• 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: Other; Required Intervention
• Patient Age: 69 YR