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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LOW VOLTAGE LEAD; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LOW VOLTAGE LEAD; No Match Back to Search Results
Model Number LEAD
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
The lead was returned with no reported event.As received, only the distal portion of the lead was returned in one piece.Electrical testing did not find any indication of conductor fractures.Shorting was found between conductors at the distal portion due to procedural damage.Visual inspection found at external insulation abrasion breaching the outer insulation distal to the suture sleeve impression caused by friction to another implanted device or feature of the patient anatomy.All other damage noted is consistent with procedural damage.
 
Event Description
This report is to advise of an event observed during analysis.Wear problem.
 
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Brand Name
LOW VOLTAGE 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 Key19068252
MDR Text Key339665555
Report Number2017865-2024-37968
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
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 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberLEAD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/20/2024
Was Device Evaluated by Manufacturer? Yes
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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