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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; PERMANENT DEFIBRILLATOR ELECTRODES
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES Back to Search Results
Model Number 7122Q/58
Device Problems Failure to Capture (1081); Retraction Problem (1536); Low impedance (2285)
Patient Problems Dyspnea (1816); Discomfort (2330); Cardiac Perforation (2513)
Event Date 01/06/2024
Event Type  Injury  
Event Description
It was reported that the patient was admitted to the hospital with shortness of breath and sternal pain.A device interrogation revealed failure to capture and a decrease in pacing impedance exhibited by the right ventricular lead.A computer tomography (ct) scan was performed and confirmed that the lead had perforated the heart.The patient was scheduled for revision and an attempt was made to reposition the lead.However, the helix failed to retract.The lead was explanted and replaced.The patient was stable.
 
Manufacturer Narrative
The reported events were cardiac perforation, failure to capture, low pacing impedance and helix mechanism issue.As received, a complete lead was returned in one piece.The reported event of helix mechanism issue was confirmed.Visual examination of the lead found the helix was extended and clogged with tissue.X-ray examination of the lead found the inner coil in the connector region was over torqued due to procedural damage.After the distal portion of the lead was cut and cleaned, torque was directly applied to the inner coil and the helix was able to retract and extend.The measured full helix extension length was within specification.The tip stiffness test was performed, and all results were within specification.The reported events of failure to capture and low pacing impedance were not confirmed.Visual and x-ray examination of the lead did not find any anomalies except for procedural damage.Electrical tests of the lead did not find any indication of conductor fractures or internal shorts.A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
 
Manufacturer Narrative
The reported events were cardiac perforation, failure to capture, low pacing impedance and helix mechanism issue.As received, a complete lead was returned in one piece.The reported event of helix mechanism issue was confirmed.Visual examination of the lead found the helix was extended and clogged with tissue.X-ray examination of the lead found the inner coil in the connector region was over torqued due to procedural damage.After the distal portion of the lead was cut and cleaned, torque was directly applied to the inner coil and the helix was able to retract and extend.The measured full helix extension length was within specification.The tip stiffness test was performed, and all results were within specification.The reported events of failure to capture and low pacing impedance were not confirmed.Visual and x-ray examination of the lead did not find any anomalies except for procedural damage.Electrical tests of the lead did not find any indication of conductor fractures or internal shorts.
 
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Brand Name
DURATA STS OPTIM 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 Key18583868
MDR Text Key333772664
Report Number2017865-2024-02054
Device Sequence Number1
Product Code NVY
UDI-Device Identifier05414734503174
UDI-Public05414734503174
Combination Product (y/n)Y
Reporter Country CodeIN
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,Followup
Report Date 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7122Q/58
Device Lot NumberA000138663
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 01/06/2024
Initial Date FDA Received01/25/2024
Supplement Dates Manufacturer Received03/04/2024
03/21/2024
Supplement Dates FDA Received03/19/2024
03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2023
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 Outcome(s) Required Intervention;
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