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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD Back to Search Results
Model Number 7122Q/58
Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Failure to Advance (2524); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2023
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 varying r wave sensing variation.During reposition, it was noted that the stylet was stuck in the right ventricular lead and the lead's helix could not be extended and retracted.The reported lead was not installed and the procedure was completed with an alternative lead on 10 feb 2023.The patient was in stable condition.
 
Manufacturer Narrative
The reported events of varying r wave sensing amplitude and stylet insertion difficulty were not confirmed, while the reported event of helix failure to extend and retract was confirmed.As received, a complete lead was returned in one-piece with the helix retracted and clogged with blood and tissue.Final analysis found the cause of the reported event of helix failure to retract and extend to the blood and tissue in the helix region.No other anomalies were identified.
 
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Brand Name
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
Type of Device
DEFIBRILLATION LEAD
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 Key16464898
MDR Text Key310493155
Report Number2017865-2023-11525
Device Sequence Number1
Product Code NVY
UDI-Device Identifier05414734503174
UDI-Public05414734503174
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
P950022
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
Report Date 04/02/2023
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 Number7122Q/58
Device Catalogue Number7122Q-58
Device Lot NumberA000133561
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 02/10/2023
Initial Date FDA Received03/01/2023
Supplement Dates Manufacturer Received03/30/2023
Supplement Dates FDA Received04/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
STYLET
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