MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. DURATA STS OPTIM ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number	7120/75
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During follow-up, increased impedance and noise leading to oversensing were observed on the device.The oversensing led to the delivery of inappropriate anti-tachycardia pacing (atp).No intervention was performed.The patient was in stable condition and there were no adverse consequences.
Event or Problem Description
Additional information was received indicating that the right ventricular (rv) lead was explanted and replaced to resolve the event.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8046537
• Report Number: 2938836-2018-12044
• Device Sequence Number: 13863924
• Product Code: LWS
• UDI-Device Identifier: 05414734502108
• UDI-Public: 05414734502108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 7120/75
• Device Lot Number: 2923939
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention