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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA AMPLATZER OCCLUDER (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER
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ST. JUDE MEDICAL, COSTA RICA LTDA AMPLATZER OCCLUDER (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
On an unknown date 2 years ago an unknown size amplatzer occluder was implanted.During routine follow-up a residual leak was noted.On an unknown date the occluder was explanted.The patient is recovering and reported to be in stable condition.Additional information is pending.
 
Manufacturer Narrative
Additional information: h6 an event of residual leak and device explant was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
AMPLATZER OCCLUDER (UNKNOWN)
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
ST. JUDE MEDICAL, COSTA RICA LTDA
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 01897 -405
CS  01897-4050
MDR Report Key10270155
MDR Text Key198692135
Report Number3008452825-2020-00336
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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