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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 2088TC/52
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2020
Event Type  Malfunction  
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 right atrial lead exhibited noise that was oversensed by the device. Programming changes were made. The patient was in stable condition.

 
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Brand NameTENDRIL STS
Type of DevicePERMANENT PACEMAKER ELECTRODE
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 Key10216158
MDR Text Key197081298
Report Number2017865-2020-08554
Device Sequence Number1
Product Code NVN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation NURSE PRACTITIONER
Type of Report Initial
Report Date 06/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2088TC/52
Device Catalogue Number2088TC-52
Device LOT NumberA000089321
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/09/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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