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

Model Number	CD3257-40
Medical Device Problem Codes	Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	07/12/2020
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
Related manufacturer reference number: 2938836-2020-07618.It was reported that the patient presented in emergency room, inappropriate shocks due to backup vvi issue was observed.The device was explanted and replaced.The patient was stable.
Event or Problem Description
New information received notes that failure to interrogate was observed.
Additional Manufacturer Narrative
Additional information: d10, h6.
Additional Manufacturer Narrative
The reported field event of backup vvi (bvvi) was confirmed in the laboratory due to event queue overflow caused by an rf ic anomaly.The reported event of inappropriate shock and failure to interrogate could not be confirmed.The device was in backup mode upon receipt, so a full normal interrogation could not be performed.However, the device¿s telemetry was normal.The device was able to be interrogated via both inductive and rf telemetry during testing in the laboratory.

• Brand Name: UNIFY ASSURA ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10320566
• Report Number: 2938836-2020-07617
• Device Sequence Number: 2912280
• Product Code: NIK
• UDI-Device Identifier: 05414734505628
• UDI-Public: 05414734505628
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2020

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: 09/30/2014
• Device Model Number: CD3257-40
• Device Catalogue Number: CD3257-40
• Device Lot Number: 4001556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2020
• Supplement Date Received by Manufacturer: 08/21/2020; 09/29/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/21/2020; 10/13/2020
• 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: TENDRIL ST; TENDRIL ST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 47