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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 1258T/86
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2023
Event Type  malfunction  
Event Description
It was reported that the left ventricular lead insulation was breached during implant procedure.The damaged lead was successfully exchanged.The patient was stable and asymptomatic.
 
Manufacturer Narrative
The reported event of insulation damage was confirmed.As received, a complete lead was returned in one piece.Visual examination found the lead body insulation was perforated/ damaged at the s-curve region consistent with guidewire damage.The cause of the reported event is consistent with procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.
 
Manufacturer Narrative
Correction: investigation conclusion previously reported as 'component failure, now corrected to 'unintended user error.
 
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Brand Name
QUICKFLEX MICRO LV LEAD
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) 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 Key17873321
MDR Text Key324976459
Report Number2017865-2023-47760
Device Sequence Number1
Product Code OJX
UDI-Device Identifier05414734502610
UDI-Public05414734502610
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,Followup,Followup
Report Date 01/03/2024
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 Number1258T/86
Device Lot NumberA000131323
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/03/2023
Initial Date FDA Received10/04/2023
Supplement Dates Manufacturer Received12/20/2023
01/02/2024
Supplement Dates FDA Received12/22/2023
01/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2022
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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