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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH Back to Search Results
Model Number 2088TC/58
Device Problem Insufficient Information (3190)
Patient Problem Arrhythmia (1721)
Event Date 02/02/2024
Event Type  malfunction  
Event Description
It was reported that during implant when the lead was being installed it was causing an arrhythmia on the right ventricular (rv) lead.The physician elected to explant and replace the rv lead.The patient was in stable condition.
 
Manufacturer Narrative
The lead was returned due to causing an arrhythmia.As received, a complete lead was returned in one piece.Electrical, mechanical, and visual analysis was normal with no anomalies found.
 
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Brand Name
TENDRIL STS
Type of Device
NO MATCH
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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18794100
MDR Text Key336770327
Report Number2017865-2024-33617
Device Sequence Number1
Product Code NVN
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
P960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2088TC/58
Device Lot NumberP000182856
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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