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

Model Number	1580/65
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2022-12904.It was reported that during routine generator exchange that device interrogation revealed caused by externalized conductors damage visually found on the right ventricular (rv).On further interrogation it showed high capture thresholds on the left ventricle (lv) lead.The physician elected to explant and replace the rv and lv lead.The patient was in stable condition before, during, and afterwards.

• Brand Name: RIATA ACTIVE FIXATION
• 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: 14744059
• Report Number: 2017865-2022-12901
• Device Sequence Number: 15105309
• Product Code: NVY
• UDI-Device Identifier: 05414734501958
• UDI-Public: 05414734501958
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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: 02/28/2011
• Device Model Number: 1580/65
• Device Catalogue Number: 3207-36
• Device Lot Number: 2693422
• Was Device Available for Evaluation?: No
• 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: 06/01/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2008
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0457-2012
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1688TC/52 PKG/STER ATRIAL; CD3357-40C UNIFYASSURA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American