MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number	LDA230Q/65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer's reference number: 2017865-2021-32404.Related manufacturer's reference number: 2017865-2021-32405.Related manufacturer's reference number: 2017865-2021-32407.It was reported the patient presented to hospital due to pocket erosion.The patient's implantable cardioverter defibrillator, right ventricular, right atrial, and left ventricular leads were explanted.A temporary pacemaker was placed.The patient was in stable condition.
Additional Manufacturer Narrative
Visual examination found no malfunctions.Full analysis not needed.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• 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: 12565281
• Report Number: 2017865-2021-32406
• Device Sequence Number: 13810178
• Product Code: NVY
• UDI-Device Identifier: 05414734507394
• UDI-Public: 05414734507394
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 11/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: LDA230Q/65
• Device Catalogue Number: LDA230Q-65
• Device Lot Number: S000015067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• 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: 09/30/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2016
• 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: QUADRA ASSURA; QUARTET; TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 136 KG