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	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 2017865-2020-17660.Related manufacturer reference number: 2017865-2020-17662.It was reported that the patient presented in clinic upon developing an infection.The patient's implantable cardioverter defibrillator, right ventricular lead, and atrial lead were explanted.The patient was stable.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.

• 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
• MDR Report Key: 10830452
• Report Number: 2017865-2020-17661
• Device Sequence Number: 19740286
• Product Code: NVY
• UDI-Device Identifier: 05414734507394
• UDI-Public: 05414734507394
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: LDA230Q/65
• Device Catalogue Number: LDA230Q-65
• Device Lot Number: S000071663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUADRA ASSURA; TENDRIL STS; QUADRA ASSURA; TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 92