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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; No Match Back to Search Results
Model Number 1456Q/86
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2024
Event Type  malfunction  
Event Description
It was reported that patient presented for a scheduled procedure.During procedure, it was noted that guidewire pierced through the left ventricular lead's body.The lead was not used, and a new lead was implanted.Patient condition was stable.
 
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Brand Name
QUARTET LEAD SMALL-S, 86 CM
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 Key19196366
MDR Text Key341250943
Report Number2017865-2024-39813
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734510158
UDI-Public(01)05414734510158(10)A000134018(17)251031
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
P030054
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 04/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1456Q/86
Device Lot NumberA000134018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/16/2022
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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