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

Model Number	CD3231-40Q
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) exhibited backup vvi due to a hardware reset.Programming changes were performed to resolve the issue.There were no patient consequences.
Event or Problem Description
New information indicates that the icd was explanted and replaced.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed by reviewing the data received from technical services.The cause of the backup event was a power-on-reset (por).However, the cause of the por could not be determined due to lack of data.Functional testing was performed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The backup operation could not be reproduced.The cause of the reported event could not be determined.

• Brand Name: UNIFY CRT-D
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15655823
• Report Number: 2017865-2022-42688
• Device Sequence Number: 2428611
• Product Code: NIK
• UDI-Device Identifier: 05414734504393
• UDI-Public: 05414734504393
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2023

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: 11/30/2012
• Device Model Number: CD3231-40Q
• Device Catalogue Number: CD3231-40Q
• Device Lot Number: 3401115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 01/23/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/09/2022; 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1258T/86 PKG/STER.; 2088/TC 52 US TENDRILACTIVE.; 7120Q/58 DURATA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male