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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 06/04/2018
Type of Reportable Event Serious Injury
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, increased impedance was observed on the right ventricular (rv) lead.The physician alleges the lead was damaged at the prior device replacement due to normal elective replacement indicator.Diagnostic imaging was inconclusive.The issue was resolved by capping and replacing the rv lead.The patient was in stable condition and experienced no adverse health consequences.
 
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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 Key7613193
Report Number2938836-2018-07935
Device Sequence Number1397070
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 Year2009
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/19/2018
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
Operator of Device Health Professional
Device Expiration Date06/12/2012
Device Model Number7171/65
Device Lot Number2915314
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 06/04/2018
Initial Report FDA Received Date06/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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