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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX LV LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX LV LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1156T/75
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 03/28/2023
Event Type  malfunction  
Manufacturer Narrative
No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found by visual inspection of the lead, an internal insulation abrasion breaching the ring electrode cable lumen at the s-curve region.
 
Event Description
This report is to advise of an event observed during analysis.
 
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Brand Name
QUICKFLEX LV 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 Key16639616
MDR Text Key312291775
Report Number2017865-2023-16178
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
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 03/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2011
Device Model Number1156T/75
Device Lot Number2704818
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2023
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2008
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 SexMale
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