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

Model Number	7121Q/52
Medical Device Problem Codes	Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for right ventricular (rv) lead and right atrial (ra) lead revision.It was previously noted that the rv lead exhibited noise over-sensing and low pacing impedance and the ra lead exhibited inappropriate automatic mode switch due to noise over-sensing.Both leads were capped and replaced on (b)(6) 2023.Patient was experiencing low blood pressure during procedure.The hypotension was resolved, and patient condition was stable post procedure.

• Brand Name: DURATA STS OPTIM 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16850908
• Report Number: 2017865-2023-18910
• Device Sequence Number: 7648076
• Product Code: NVY
• UDI-Device Identifier: 05414734503211
• UDI-Public: 05414734503211
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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: 10/31/2011
• Device Model Number: 7121Q/52
• Device Catalogue Number: 7121Q-52
• Device Lot Number: 3242744
• 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: 04/12/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2010
• 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; QUARTETE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG