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

Model Number	7121/60
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for a follow up.The patient's right ventricular (rv) lead exhibited noise over-sensing.Lead revision was discussed, but no interventions were made or reported.The patient was in stable condition.
Event or Problem Description
New information noted that the right ventricular lead kept oversensing noise.The patient had presented for a generator change on august 5, 2022, but the lead revision was not performed due to patient access issue.The lead remained active and would be monitored.The patient was stable.
Event or Problem Description
New information noted that the right ventricular lead was capped and replaced (b)(6) 2022.The patient was in stable condition throughout the procedure.
Additional Manufacturer Narrative
The reported event of oversensing was not confirmed.As received, only the connector portion of the lead was returned in one piece.Electrical, visual, and x-ray examination of the lead did not find any anomalies with the exception of procedural damage.

• Brand Name: DURATA STS OPTIM 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: 15115407
• Report Number: 2017865-2022-16234
• Device Sequence Number: 20295968
• Product Code: LWS
• UDI-Device Identifier: 05414734502115
• UDI-Public: 05414734502115
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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,Followup,Followup
• Report Date (Section B): 12/08/2022

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: 03/31/2011
• Device Model Number: 7121/60
• Device Catalogue Number: 7121-60
• Device Lot Number: 0002142556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 10/28/2022; 11/22/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/18/2022; 11/04/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1888TC LEAD; CD2357-40C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male