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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA PASSIVE FIXATION; Permanent defibrillator electrodes
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA PASSIVE FIXATION; Permanent defibrillator electrodes Back to Search Results
Model Number 1570
Device Problems Fracture (1260); Over-Sensing (1438)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that the right ventricular (rv) lead exhibited oversensing of noise.The patient presented to the clinic, and the noise could be reproduced.A lead conductor fracture is suspected to be the cause of the reported observations.As a result, reprogramming was performed.The patient will be clinically evaluated in order to decide next actions.No adverse patient effects were reported.The lead remains in service.
 
Manufacturer Narrative
Received voluntary medwatch mw5151660.
 
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Brand Name
RIATA PASSIVE FIXATION
Type of Device
Permanent defibrillator electrodes
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 Key18975225
MDR Text Key338620607
Report Number2017865-2024-35827
Device Sequence Number1
Product Code NVY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/25/2024
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 Number1570
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/06/2024
Initial Date FDA Received03/25/2024
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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