MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CURRENT ACCEL VR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1215-36
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
During implant procedure, the physician noted that the silicone seal covering the set screw on the device header was missing.A new device was implanted and the patient was in stable condition.
Additional Manufacturer Narrative
The reported field event of missing septum was confirmed in the lab.The device was at elective replacement indicator (eri) when received.Longevity calculation showed the battery depletion was normal based upon programmed settings and usage data.The device was tested on the bench using test leads and resistors; test leads were fully inserted and secured.Telemetry, sensing, pacing, pacing lead impedance (pli), high voltage lead impedance (hvli), patient notification, and high voltage shock were tested.No anomaly was detected.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The cause of the field event remains undetermined.

• Brand Name: CURRENT ACCEL VR, 36J
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7877664
• Report Number: 2938836-2018-10596
• Device Sequence Number: 18879969
• Product Code: NVZ
• UDI-Device Identifier: 05414734502634
• UDI-Public: 05414734502634
• 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: 2010
• 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): 09/19/2019

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: 10/31/2010
• Device Model Number: CD1215-36
• Device Lot Number: 2921305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1