MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7121Q/58

Device Problems Fracture (1260); High impedance (1291); Incorrect Measurement (1383); Over-Sensing (1438); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.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 Description

It was reported that the patient presented for follow up with the right ventricular lead exhibiting increased pacing impedance.The physician acknowledged that the increase may have been attributed to patient factors.Programming interventions were made.The patient was in stable condition.

Event Description

New information received notes that the right ventricular lead was capped and replaced on (b)(6) 2020 due to fracture.The patient was in stable condition.

Manufacturer Narrative

Correction: previously reported b5 from 9/10/2020 should have been "new information received notes that the right ventricular lead exhibited over-sensing and high capture threshold.High voltage impedance values were also unable to be obtained.No interventions have been reported.The patient was stable and non-pacing dependent.", previously reported g4 should have been 10/5/2020 rather then blank, h6.

Event Description

New information received notes that the right ventricular lead exhibited over-sensing and high capture threshold.No interventions have been reported.The patient was stable and non-pacing dependent.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10417925
• MDR Text Key: 203279008
• Report Number: 2017865-2020-11685
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503167
• UDI-Public: 05414734503167
• Combination Product (y/n): N
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: 7121Q/58
• Device Catalogue Number: 7121Q-58
• Device Lot Number: 4360468
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention