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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/52
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/18/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No complaint was received with return of the device.Failure event observed during analysis.Final analysis found only the connector portion of the lead was returned in one piece measuring 8.0 cm.An external insulation abrasion breaching the optim sheath was noted at 6.6 cm to 6.8 cm from the connector pin.The insulation abrasion found was consistent with friction to the device can.
 
Event or Problem Description
This report is to advise of an event observed during analysis.
 
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Brand Name
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
Common Device Name
DEFIBRILLATION LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key12144691
Report Number2017865-2021-24211
Device Sequence Number4260022
Product Code NVY
UDI-Device Identifier05414734503211
UDI-Public05414734503211
Combination Product (Y/N)Y
Initial Reporter CountryUS
PMA/510(K) Number
P950022
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/09/2021
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 Other
Device Expiration Date12/31/2010
Device Model Number7121Q/52
Device Catalogue Number7121Q-52
Device Lot Number2899042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2021
Initial Report FDA Received Date07/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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