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

Model Number	CD1311-36
Medical Device Problem Codes	Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	07/09/2020
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 the patient presented to the clinic with an episode of inappropriate shock due to electromagnetic interference (emi) oversensing.Upon review of the episode, it appeared to resemble oversensing of electrocautery.However, the clinician was not able to confirm that the patient had a procedure at the time of the event.The patient was scheduled for continued regular follow-up.
Event or Problem Description
New information received from the following pacemaker clinic stated that the patient was doing fine in the previous follow up in clinic.
Event or Problem Description
New information received stated that the patient was having a hip surgery at the time of the event causing the emi oversensing.

• Brand Name: ELLIPSE VR ICD
• 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: 10345179
• Report Number: 2017865-2020-10219
• Device Sequence Number: 824690
• Product Code: NVZ
• UDI-Device Identifier: 05414734506106
• UDI-Public: 05414734506106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2020

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: 01/31/2014
• Device Model Number: CD1311-36
• Device Catalogue Number: CD1311-36
• Device Lot Number: 3756195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 09/03/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/19/2020; 09/03/2020
• 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
• Patient Age: 82 YR