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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 Problems Difficult to Fold, Unfold or Collapse (1254); Capturing Problem (2891); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Event Description
It was reported that the patient presented to the hospital for a scheduled procedure.During procedure, the right ventricular (rv) lead had an elevated capture threshold and a sensing issue.Upon multiple attempts of repositioning the rv lead, the helix was unable to be extended.The rv lead was removed and replaced on (b)(6) 2024.The patient was in stable condition.
 
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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 Key19173197
MDR Text Key340931918
Report Number2017865-2024-39504
Device Sequence Number1
Product Code NVN
UDI-Device Identifier05414734502894
UDI-Public(01)05414734502894(10)P000186416(17)261031
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
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2088TC/58
Device Lot NumberP000186416
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/19/2023
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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