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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 Retraction Problem (1536); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Related manufacturer reference number: 2017865-2023-13046, related manufacturer reference number: 2017865-2023-13047.It was reported that the patient twiddled their implantable cardioverter defibrillator system resulting in movement of the pulse generator and full dislodgement of their right ventricular lead and atrial lead.The leads failed to be repositioned due to helix retraction failure and inability to advance the leads through the stylets.The device was repositioned and the leads were explanted and replaced.The patient was stable.
 
Manufacturer Narrative
The reported events were lead dislodgement, twiddlers syndrome, failure to advance stylet were not confirmed and the complaint of helix mechanism issue was confirmed.As received, a complete lead was returned in one piece with the helix found retracted and clogged with blood/ tissue.The cause of helix mechanism issue and failure to advance stylet was isolated to the inner coil and helix being clogged with blood.No other anomalies were found.
 
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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 Key16496320
MDR Text Key310805236
Report Number2017865-2023-13048
Device Sequence Number1
Product Code NVY
UDI-Device Identifier05414734503174
UDI-Public05414734503174
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 03/27/2023
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 Catalogue Number7122Q-58
Device Lot NumberA000130606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/16/2023
Initial Date FDA Received03/07/2023
Supplement Dates Manufacturer Received03/24/2023
Supplement Dates FDA Received03/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient SexFemale
Patient Weight96 KG
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