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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2024
Event Type  malfunction  
Event Description
It was reported that the patient presented for an implant procedure.During the procedure, it was noted that while attempting the lead implant, the lead was damaged.The lead was not used, and a new lead was implanted.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 Key18987901
MDR Text Key338726592
Report Number2017865-2024-35832
Device Sequence Number1
Product Code NVN
UDI-Device Identifier05414734502894
UDI-Public05414734502894
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 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2088TC/58
Device Lot NumberP000183049
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2023
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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