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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA; DEFIBRILLATION LEAD
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA; DEFIBRILLATION LEAD Back to Search Results
Model Number 7131/65
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/19/2021
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 a patient presented in-clinic.Upon interrogation, the patient's right ventricular (rv) lead exhibited high defibrillation impedance.The rv lead was capped and replaced on (b)(6) 2021.The patient did not suffer any adverse consequences throughout the event.
 
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Brand Name
DURATA
Common Device Name
DEFIBRILLATION LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11967735
Report Number2017865-2021-20445
Device Sequence Number3508438
Product Code LWS
UDI-Device Identifier05414734505123
UDI-Public05414734505123
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P950022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/09/2021
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 Date10/31/2011
Device Model Number7131/65
Device Catalogue Number7131-65
Device Lot Number2719397
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 05/19/2021
Initial Report FDA Received Date06/09/2021
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 Required Intervention;
Patient Age70 YR
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