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

Model Number	CD2275-36Q
Medical Device Problem Codes	Connection Problem (2900); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
During a follow-up in clinic, there was decreased sensing and an increased capture threshold noted on the right ventricular (rv) lead.Diagnostic imaging was performed and revealed that the device had migrated in the pocket and caused both the rv and right atrial (ra) leads to dislodge.A surgery was performed to address the dislodgement and the sensing value of the ra lead decreased.Both leads were then explanted and replaced.When the new leads were being reconnected to the old device, the rv lead could not be placed in the device header, so the device was also replaced.The patient was stable following the procedure and suffered no adverse consequences due to the event.Related manufacturer report numbers: 2938836-2018-10423, 2938836-2018-10424.
Additional Manufacturer Narrative
As received, interrogation of the device revealed the device was above eri.Telemetry, sensing, pacing, pli, hvli, patient notifier, hv shock and hv impedance were tested.No anomaly was detected.A torque driver was unable to engage the rv df4 set screw during testing.The set screw was found to be completely backed out from the set screw threads.Septum material was observed inside the set screw hex cavity.When the screw was re-engaged with the connector block, the screw operated normally in affixing a lead to the device.The device's functionality was bench tested; the test leads were fully inserted and secured without difficulty.The reported event of rv lead insertion difficulty was verified in the lab.

• Brand Name: ELLIPSE DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7850709
• Report Number: 2938836-2018-10424
• Device Sequence Number: 11097140
• Product Code: NVZ
• UDI-Device Identifier: 05414734505918
• UDI-Public: 05414734505918
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 02/28/2019
• Device Model Number: CD2275-36Q
• Device Lot Number: S000038112
• 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: 08/28/2018
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2088TC/52, (B)(4); 7122Q/58, (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention