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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL SDX LEAD; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL SDX LEAD; No Match Back to Search Results
Model Number 1688TC
Device Problems Failure to Capture (1081); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the patient's right atrial lead exhibited a threshold anomaly.When the threshold test was conducted, the device failed to capture.The atrial lead also exhibited a lowering in p wave sensing after the patient had an open heart surgery.No interventions were performed.The patient's condition was unknown.
 
Manufacturer Narrative
Voluntary event report was received.Medwatch: mw5151524.
 
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Brand Name
TENDRIL SDX LEAD
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 Key18966564
MDR Text Key338885400
Report Number2017865-2024-35744
Device Sequence Number1
Product Code NVN
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1688TC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/01/2024
Initial Date FDA Received03/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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