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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. DURATA STS OPTIM PASSIVE FIXATION; DEFIBRILLATION LEAD
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ST. JUDE MEDICAL, INC. DURATA STS OPTIM PASSIVE FIXATION; DEFIBRILLATION LEAD Back to Search Results
Model Number 7171/65
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/28/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined. .
 
Event or Problem Description
During follow-up, high defibrillation impedance was noted on the right ventricular lead.No intervention was performed, the lead remains implanted and will continue to be monitored.The patient was in stable condition.
 
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Brand Name
DURATA STS OPTIM PASSIVE FIXATION
Common Device Name
DEFIBRILLATION LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8331287
Report Number2938836-2019-00998
Device Sequence Number1619866
Product Code LWS
UDI-Device Identifier05414734502443
UDI-Public05414734502443
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P950022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/12/2019
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
Operator of Device Health Professional
Device Expiration Date06/10/2011
Device Model Number7171/65
Device Lot Number2914881
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/28/2019
Initial Report FDA Received Date02/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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