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

Model Number 7122/65

Device Problems Break (1069); Failure to Capture (1081); Failure to Sense (1559)

Patient Problem Syncope/Fainting (4411)

Event Date 09/04/2022

Event Type  Injury  

Event Description

It was reported that the pacing patient presented for follow-up after syncopal episodes.Upon interrogation, there was no sensing or capture through the right ventricular lead.A chest x-ray was unremarkable.The patient was scheduled for lead revision on (b)(6) 2022, where multiple unsuccessful attempts were made to reposition the lead.The lead was capped and replaced.The patient was stable.

Event Description

Related manufacturer reference number: 2017865-2022-39889.It was reported that the pacing patient presented for follow-up after syncopal episodes.Upon interrogation, there was no sensing or capture through the right ventricular lead.A chest x-ray was unremarkable.The patient was scheduled for lead revision on (b)(6) 2022 where the lead was capped and replaced.The initial replacement lead was repositioned multiple times, and ultimately not used as the physician believed there was some damage to the helix.A new lead was used instead and implanted successfully.The patient was stable.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: 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: 15481159
• MDR Text Key: 300566464
• Report Number: 2017865-2022-39254
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: 05414734502153
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: 7122/65
• Device Catalogue Number: 7122-65
• Device Lot Number: 0002687739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ELLIIPSE DR; OPTISENSE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male