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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA ACTIVE FIXATION; DEFIBRILLATION LEAD
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA ACTIVE FIXATION; DEFIBRILLATION LEAD Back to Search Results
Model Number 1580/65
Device Problems High impedance (1291); Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
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 Description
It was reported that patient presented remotely via merlin.Net.Upon review of the transmission, it was noted that the right ventricular - rv lead exhibited high defibrillation impedance due to possible calcification.The rv lead was reprogrammed and the patient experienced no consequences.
 
Manufacturer Narrative
Correction: h6 - health effect - impact code should be "4641 - unexpected medical intervention" instead of "2199 - no health consequences or impact".
 
Manufacturer Narrative
Correction: h6 - "2317 - device contamination with body fluid" should be excluded.
 
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Brand Name
RIATA ACTIVE FIXATION
Type of Device
DEFIBRILLATION LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11327846
MDR Text Key231931079
Report Number2017865-2021-08694
Device Sequence Number1
Product Code NVY
Combination Product (y/n)N
PMA/PMN Number
P950022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2008
Device Model Number1580/65
Device Lot Number0002200334
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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