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

Model Number	CD3257-40
Medical Device Problem Codes	Communication or Transmission Problem (2896); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
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.Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented via remote transmission.Upon review, the implantable cardioverter defibrillator was in backup vvi mode due to event queue overflow.The patient was reported to have felt poor due to a lack of biventricular pacing support.Programming changes were made.The patient was in stable condition.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
New information received notes the implantable cardioverter defibrillator reached normal elective replacement indicator (eri).The physician explanted and replaced the device.The patient was in stable condition.
Additional Manufacturer Narrative
The reported field event of backup vvi (bvvi) was confirmed in the laboratory and was due to event queue overflow the device was tested on the bench and bvvi was noted.The cause of the bvvi was event queue overflow of the radio frequency (rf) module.

• 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: 9722824
• Report Number: 2017865-2020-02252
• Device Sequence Number: 361956
• Product Code: NIK
• UDI-Device Identifier: 05414734505628
• UDI-Public: 05414734505628
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2020

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: 12/31/2013
• Device Model Number: CD3257-40
• Device Catalogue Number: CD3257-40
• Device Lot Number: 3743084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 06/11/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/23/2020; 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR