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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES Back to Search Results
Model Number LDA210Q/58
Device Problems High impedance (1291); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2024
Event Type  malfunction  
Event Description
It was reported that the patient presented during implant procedure.During procedure, it was noted that the right ventricular lead exhibited high pacing impedance and varying sensing threshold.The reported lead was not installed.The patient was in stable condition.
 
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Brand Name
OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
Type of Device
PERMANENT DEFIBRILLATOR ELECTRODES
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 Key18699646
MDR Text Key335280208
Report Number2017865-2024-22506
Device Sequence Number1
Product Code NVY
UDI-Device Identifier05414734507325
UDI-Public05414734507325
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P950022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/06/2024
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 NumberLDA210Q/58
Device Lot NumberA000151693
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/26/2024
Initial Date FDA Received02/13/2024
Supplement Dates Manufacturer Received06/06/2024
Supplement Dates FDA Received06/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2023
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 Age69 YR
Patient SexFemale
Patient Weight61 KG
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