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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 Codes Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/25/2021
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
It was reported that the right ventricular lead exhibited noise.The lead was explanted and replaced.The patient was stable.
 
Event or Problem Description
Related manufacturer's number: 2017865-2021-11236.New information states that the patient inappropriately received atp due to noise oversensing.
 
Additional Manufacturer Narrative
A partial lead was returned in two pieces.Visual examination found an internal insulation abrasion was found between the shock coils breaching the ring electrode and inner coil lumens with abrasion to one ring electrode cable coating and ptfe liner at 7.7 ¿ 9.5 cm from the distal tip.The optim sheath in this region was not abraded but procedural damage was noted.The cause of the reported events was due to the internal insulation abrasion with abraded ptfe liner and etfe cable coating.
 
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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 Key11580574
Report Number2017865-2021-13065
Device Sequence Number17170865
Product Code NVY
UDI-Device Identifier05414734503211
UDI-Public05414734503211
Combination Product (Y/N)Y
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
P950022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 07/26/2021
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 Date03/31/2013
Device Model Number7121Q/52
Device Catalogue Number7121Q-52
Device Lot Number3645019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/05/2021
Supplement Date Received by Manufacturer06/15/2021
07/06/2021
Initial Report FDA Received Date03/29/2021
Supplement Report FDA Received Date06/23/2021
07/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
FORTIFY DR, U1.6 SJ4.US.
Outcome Attributed to Adverse Event Required Intervention;
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