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

Model Number	CD3257-40Q
Medical Device Problem Codes	Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient presented in clinic for follow up.Upon interrogation, the device could not interrogate.The device was found in backup vvi operation.The device was explanted and replaced on (b)(6) 2019.The patient was stable before, during and after the procedure.
Additional Manufacturer Narrative
The reported field event of backup vvi (bvvi) was confirmed in the laboratory and was due to a por (power on reset) that occurred during hv charging.The device was tested on the bench and was revealed to be above eri when received.The cause of the bvvi could not be reproduced in the laboratory; hence the cause of the field event could not be conclusively determined.

• Brand Name: UNIFY ASSURA 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: 8698626
• Report Number: 2017865-2019-09615
• Device Sequence Number: 2308389
• Product Code: NIK
• UDI-Device Identifier: 05414734505635
• UDI-Public: 05414734505635
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2020

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: 04/30/2014
• Device Model Number: CD3257-40Q
• Device Catalogue Number: CD3257-40Q
• Device Lot Number: 3841442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 02/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 101