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

Model Number	7171/65
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Heart Failure (2206)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
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
It was reported that the patient was admitted to the hospital for heart failure.Upon interrogation of the device, reproducible noise was noted on the right ventricular lead.The device had a history of noise in 2017 and was reprogrammed.The patient was stable.No additional information was reported.
Event or Problem Description
New information noted that the noise occurred after atrial pacing.The device was programmed to vvi.This resolved the noise.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8149371
• Report Number: 2017865-2018-18651
• Device Sequence Number: 1459779
• Product Code: LWS
• UDI-Device Identifier: 05414734502443
• UDI-Public: 05414734502443
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2012
• Device Model Number: 7171/65
• Device Lot Number: 2915339
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1