MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR ICD; Pulse generator, permanent, implantable

Model Number	CD1311-36Q
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mboa: long charge time was confirmed by analysis.Review of device data showed the device had a charge time out during capacitor maintenance.The high-voltage capacitors were sent to the manufacturer for analysis.The cause of the long charge time was due to an internal high voltage capacitor anomaly associated with the abbott ellipse vr/dr implantable cardioverter defibrillator (icds) field action in august 2014.Mboa: premature battery depletion was confirmed by analysis.Interrogation of the device revealed the device was at elective replacement indicator (eri) when received.A longevity calculation was performed and found the battery depletion was premature based on the device usage.Device image indicated normal current drain during implant period and no high current drain sources were found throughout bench and environmental stress testing.Telemetry, impedance, sensing pacing and high voltage (hv) output functions of the device were tested and found to be normal.The battery analysis by the manufacturer found the battery was normal.The cause of the premature battery depletion could not be determined.
Event or Problem Description
This report is to advise of an event observed during analysis.Premature battery depletion, charge time out.

• Brand Name: ELLIPSE VR ICD
• Common Device Name: Pulse generator, permanent, implantable
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18193720
• Report Number: 2017865-2023-73049
• Device Sequence Number: 7715315
• Product Code: NVZ
• UDI-Device Identifier: 05414734506113
• UDI-Public: 05414734506113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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: Other
• Device Expiration Date: 02/28/2014
• Device Model Number: CD1311-36Q
• Device Lot Number: 3845459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2012
• 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
• Patient Sex: Unknown