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

Model Number 7121/65

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285); Low Sensing Threshold (2575); High Capture Threshold (3266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.Further information was requested but not received.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 patient presented to the emergency room on (b)(6) 2020 after receiving an appropriate shock for a ventricular fibrillation episode.Device interrogation revealed that the patient's right ventricular lead was exhibiting noise over-sensing immediately following the ventricular fibrillation termination.Decreased r-wave sensing amplitudes were also noted.Programming changes were attempted, but the noise could not be avoided.The noise was consistent with the patient's left ventricular assist device (lvad) that was implanted in 2019.Further device interrogation on (b)(6) 2020 revealed that the lead experienced a significant pacing impedance drop at the time of the lvad implant, and that the lead had its capture threshold increase.Lead was capped and replaced on (b)(6) 2020.Patient had no symptoms as a result of the lead malfunction and was stable after the procedure.

• 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: 10734523
• MDR Text Key: 213033976
• Report Number: 2017865-2020-16122
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502122
• UDI-Public: 05414734502122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: 7121/65
• Device Catalogue Number: 7121-65
• Device Lot Number: 0002655979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2008
• 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
• Patient Outcome(s): Required Intervention