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

Model Number	CD3257-40
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/19/2019
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 for an elective generator changeout procedure with discomfort in the pocket.The patient alleged that the implantable cardioverter defibrillator had migrated.The physician explanted and replaced the device.The patient was discharged post-procedure.
Additional Manufacturer Narrative
As received, an implantable cardioverter defibrillator was returned above normal elective replacement indicator.No anomalies were found.

• 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: 9954387
• Report Number: 2017865-2020-04977
• Device Sequence Number: 2814756
• Product Code: NIK
• UDI-Device Identifier: 05414734505628
• UDI-Public: 05414734505628
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 12/31/2014
• Device Model Number: CD3257-40
• Device Catalogue Number: CD3257-40
• Device Lot Number: 4140105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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: 64 YR
• Patient Weight: 61