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

Model Number	CD2311-36
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
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 in hospital for a scheduled generator change.During the procedure, the physician was unable to remove the right ventricular (rv) lead pin for the rv port after successfully engaging and loosening the set screw.The physician proceeded to remove the silicone septum and set screw from the device header using mosquito forceps but remained unable to remove the rv lead pin from the rv port.The physician attempted to apply leverage to the lead pin through the set screw channel using various instruments (tip scalpel, tip mosquito forceps, long end of an "l" shaped wrench), without success.Orthpedic bone nippers were subsequently used to cut through the header to free the lead, with success.The rv lead was tested following it's removal, with pacing system analyzer measurements stable when compared to testing performed in holding prior to case start.The case proceeded and concluded without further complication.
Additional Manufacturer Narrative
The reported event of a header anomaly could not be confirmed.As received, the device was at eri.Longevity analysis found the battery depletion to be normal.Due to the condition of the device upon receipt, conclusive analysis could not be performed.

• Brand Name: ELLIPSE DR 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: 11700955
• Report Number: 2017865-2021-15708
• Device Sequence Number: 11641483
• Product Code: NVZ
• UDI-Device Identifier: 05414734505987
• UDI-Public: 05414734505987
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 11/30/2013
• Device Model Number: CD2311-36
• Device Catalogue Number: CD2311-36
• Device Lot Number: 3715630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/20/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR