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

Model Number	7131/65
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Codes	Arrhythmia (1721); Discomfort (2330)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2023-01215.It was reported that a patient presented in-clinic.Upon examination, it was noted that the patient's implantable cardioverter defibrillator was found to have exhibited an unspecified output issue, and the patient's right ventricular lead was found to have over-sensing of noise.Corrective programming changes were made, and further surgical intervention was planned.The patient was stable throughout.
Additional Manufacturer Narrative
The reported event of over-sensing noise was confirmed.As received, a partial lead was returned in two pieces.Visual inspection found external insulation abrasion breaching the outer insulation and ptfe liner of the ring electrode coil exposing the ring electrode coil at is 1 connector leg consistent with friction to the device can.The cause of the reported event was due to exposure of ring electrode coil at the abrasion zone.

• Brand Name: DURATA
• 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: 16180336
• Report Number: 2017865-2023-01216
• Device Sequence Number: 19405533
• Product Code: LWS
• UDI-Device Identifier: 05414734505123
• UDI-Public: 05414734505123
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• 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): 02/27/2023

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: 11/30/2011
• Device Model Number: 7131/65
• Device Catalogue Number: 7131-65
• Device Lot Number: 2736257
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 01/09/2023; 02/14/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 01/30/2023; 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male