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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 7121Q/65
Device Problem Low impedance (2285)
Patient Problem Death (1802)
Event Date 07/02/2018
Event Type  Death  
Event Description
It was reported that a patient received a high voltage shock. After delivery of the shock, the implantable cardioverter defibrillator exhibited low impedance on the right ventricular lead; lead issue was suspected. Manual high voltage impedance test revealed normal range measurements. The patient¿s condition was stable. Later, the device failed to deliver therapy and the patient had entered a vegetative state. The patient died on (b)(6) 2018.
 
Manufacturer Narrative
External insulation abrasion was noted at 15. 2-15. 5 cm from the pin consistent with lead friction to the icd can. Internal insulation abrasion under the svc shock coil was noted at 25. 5 cm from the distal tip. External insulation abrasion was noted at 15. 8-16. 2 cm from the distal tip consistent with lead friction to another device or feature of patient anatomy. Internal insulation abrasion under the svc shock coil breaching the right ventricular lumen was noted at 27. 2-27. 8 cm from the distal tip. The etfe coating was abraded at this location with slight melting of the conductor. This is consistent with the observation from the field of low defibrillation impedance.
 
Event Description
New information noted that the patient was driving during the time of the event. The patient pulled over and paramedics were called. The paramedics shocked the patient twice, used epinephrine twice, and used bag valve ventilation to transport the patient to the emergency room. Upon arrival at the er, the patient was immediately intubated and transferred to intensive care unit. Treating physicians observed implantable cardioverter defibrillator failure.
 
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Brand NameDURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
Type of DeviceDEFIBRILLATION 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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7724171
MDR Text Key115155597
Report Number2017865-2018-10910
Device Sequence Number1
Product Code NVY
UDI-Device Identifier05414734503228
UDI-Public05414734503228
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2012
Device Model Number7121Q/65
Device Catalogue Number7121Q-65
Device Lot Number3408575
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/26/2018 Patient Sequence Number: 1
Treatment
(B)(4)
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