MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF1COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3249-40
Medical Device Problem Codes	Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital for a follow-up on (b)(6) 2022.Review of the transmission revealed a premature decline in the battery life of the implantable cardioverter defibrillator (icd).The icd was explanted and replaced on (b)(6) 2022.The patient was in stable condition.
Additional Manufacturer Narrative
Correction - b5- added new inappropriate therapy information.Correction - h6 - added inappropriate/inadequate shock/stimulation codes.
Event or Problem Description
New information received notes the implantable cardioverter defibrillator (icd) delivered inappropriate therapy which resulted in premature battery depletion.
Additional Manufacturer Narrative
The reported event of premature depletion and inappropriate therapy was not confirmed.Interrogation of the device revealed the device was at elective replacement indicator (eri) when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF1COMP
• 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: 15443425
• Report Number: 2017865-2022-38481
• Device Sequence Number: 4750310
• Product Code: NIK
• UDI-Device Identifier: 05414734504539
• UDI-Public: 05414734504539
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2022

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: 10/31/2019
• Device Model Number: CD3249-40
• Device Catalogue Number: CD3249-40
• Device Lot Number: S000060012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• 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: 08/29/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 09/26/2022
• Initial Report FDA Received Date: 09/18/2022
• Supplement Report FDA Received Date: 09/20/2022; 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown