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

Model Number	7171Q/65
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the asymptomatic patient presented for a follow up in clinic with a right ventricular lead that exhibited lead noise, r-wave amplitude variation, and high pacing impedance due to suspected conductor fracture.Lead revision was discussed; no interventions were reported.The patient was in stable condition.
Additional Manufacturer Narrative
The reported events of fracture, sensing noise, r-wave amplitude variation, and high pacing impedance were confirmed.As received, a partial lead was returned in two pieces.Visual and x-ray examination found a possible inner coil fracture at the middle region of the lead.Additional analysis found that all four filars of the inner coil were fractured.The cause of the reported events was due to fracture of inner coil consistent with fatigue fracture.
Event or Problem Description
New information received noted that the lead noise was over-sensed.The lead was explanted and replaced.The patient was in stable condition post-procedure.

• Brand Name: DURATA STS OPTIM PASSIVE 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: 14079310
• Report Number: 2017865-2022-07660
• Device Sequence Number: 17461967
• Product Code: NVY
• UDI-Device Identifier: 05414734503297
• UDI-Public: 05414734503297
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 06/30/2022

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: 10/31/2010
• Device Model Number: 7171Q/65
• Device Catalogue Number: 7171Q-65
• Device Lot Number: 2863696
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 06/28/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 04/14/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2009
• 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: ELLIPSE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 91 KG