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

Model Number	7131/65
Medical Device Problem Codes	Failure to Capture (1081); Over-Sensing (1438)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	06/22/2020
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
Related manufacturer reference number: 2017865-2020-08953.It was reported that patient underwent a procedure unrelated to the devices on (b)(6) 2020.Towards the end of the procedure, patient's right ventricular lead exhibited crosstalk over-sensing and failed to capture.Physician attempted to reprogram the device.Patient then went asystole.Device was reprogrammed again and capture resumed.Further investigation found that patient's right atrial lead may have also been over-sensing and inhibiting pacing.Both leads were capped and replaced on (b)(6) 2020.Patient condition after the procedure was stable.
Event or Problem Description
Related manufacturer reference number: 2017865-2020-08892, 2017865-2020-08953, 2017865-2020-12087, 2017865-2020-12089.New information received noted that during the procedure to cap and replace the right ventricular and atrial leads, the two right ventricular and atrial replacement leads were contaminated.The leads were exchanged for new ones and the procedure was completed successfully.Patient had no symptoms and was stable after the event.

• Brand Name: DURATA
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10258764
• Report Number: 2017865-2020-08892
• Device Sequence Number: 2212520
• Product Code: LWS
• UDI-Device Identifier: 05414734505123
• UDI-Public: 05414734505123
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: 12/31/2011
• Device Model Number: 7131/65
• Device Catalogue Number: 7131-65
• Device Lot Number: 2771699
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUARTET LEAD; TENDRIL ST LEAD; TENDRIL STS LEAD; TENDRIL ST LEAD
• Outcome Attributed to Adverse Event: Required Intervention