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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ABBOTT LOW VOLTAGE LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ABBOTT LOW VOLTAGE LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number LV LEAD
Device Problem Capturing Problem (2891)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Related manufacturing reference number: 2017865-2023-38858.It was reported via the food and drug association (fda) medwatch program that the patient had two leads in their pacemaker system that had high capture thresholds.Both leads were explanted.Further information was not provided.
 
Manufacturer Narrative
Sus voluntary event report was received.Medwatch: mw5119529.
 
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Brand Name
ABBOTT LOW VOLTAGE LEAD
Type of Device
PERMANENT PACEMAKER ELECTRODE
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 Key17585005
MDR Text Key321548045
Report Number2017865-2023-38859
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLV LEAD
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/31/2023
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
Patient Outcome(s) Required Intervention;
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