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

Model Number	CD1275-36Q
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to procedure, it was reported that the device was found to be in back up mode (bvvi).The device was never used and no patient was involved.
Additional Manufacturer Narrative
Upon receipt, the device was interrogated on a programmer and normal communication was established.The programmer printouts were obtained, and a device image was also obtained.Review of the programmer printouts and device image confirmed that the device was in backup mode and the reason for the reset was due to a watchdog error.Device functional testing was performed, and the impedance, sensing, pacing output, high voltage (hv) output, and patient notifier were all tested, and no anomalies were noted.The reset was unable to be reproduced in the lab and the root cause of the reset remains undetermined.The reported event of backup mode was confirmed.

• Brand Name: ELLIPSE VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7878620
• Report Number: 2938836-2018-10621
• Device Sequence Number: 11275138
• Product Code: NVZ
• UDI-Device Identifier: 05414734506038
• UDI-Public: 05414734506038
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: CD1275-36Q
• Device Lot Number: S000056011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1