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

Model Number	CD3231-40Q
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
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 an implantable cardioverter defibrillator was explanted.Premature battery depletion was a possibility.
Event or Problem Description
New information notes that the premature battery depletion was not alleged.The patient was stable during procedure.
Additional Manufacturer Narrative
"interrogation of the device revealed the device was at eri when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.The device functionality was bench tested and no anomaly was detected.Based on this information, there was no evidence of device malfunction.

• 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
• MDR Report Key: 9604873
• Report Number: 2017865-2020-00677
• Device Sequence Number: 2677630
• Product Code: NIK
• UDI-Device Identifier: 05414734504393
• UDI-Public: 05414734504393
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2020

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: 04/30/2013
• Device Model Number: CD3231-40Q
• Device Catalogue Number: CD3231-40Q
• Device Lot Number: 3530403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 03/23/2020; 03/23/2020
• Initial Report FDA Received Date: 01/19/2020
• Supplement Report FDA Received Date: 01/24/2020; 03/23/2020; 03/23/2020
• 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