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

Model Number	CD1275-36Q
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Related to manufacturer report number: 2938836-2018-08519.During follow-up, increased high voltage lead impedance was observed on the right ventricular (rv) lead.A new rv lead was implanted to try and resolve the issue but the impedance remained high.The issue was resolved by explanting and replacing the device.The old lead was connected and the new lead was electively explanted.The patient was in stable condition and experienced no adverse health consequences.
Additional Manufacturer Narrative
Additional information: visual inspection revealed no anomalies.Resistance measurements were performed to verify the header to hybrid connections.High impedance was found on the right ventricular (rv) header to hybrid connection.Diagnostic imaging revealed the rv connector block wire to be broken at the weld.The reported event of increased high voltage (hv) lead impedance was confirmed.The broken connection caused the increased hv lead impedance observed in the field.

• 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: 7690019
• Report Number: 2938836-2018-08522
• Device Sequence Number: 16345061
• 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
• 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): 10/19/2018

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: 03/31/2018
• Device Model Number: CD1275-36Q
• Device Lot Number: S000024522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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: (B)(4)