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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENTERRA MEDICAL, INC. ENTERRA II IPG; GASTRIC STIMULATOR
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ENTERRA MEDICAL, INC. ENTERRA II IPG; GASTRIC STIMULATOR Back to Search Results
Model Number 37800
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 11/03/2023
Event Type  malfunction  
Event Description
Patient mentioned they had their enterra system removed because the leads were starting to go towards their small intestine and scar tissue was developing.After having the enterra removed they noticed a mass of hard scar tissue at the removal site.Patient wanted to know if this is normal.Redirected to discuss with managing physician.Transferred patient to prs to update enterra records, however prs noted they no longer maintain enterra registration records and will direct the patient to enterra medical.No analysis results recorded.
 
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Brand Name
ENTERRA II IPG
Type of Device
GASTRIC STIMULATOR
Manufacturer (Section D)
ENTERRA MEDICAL, INC.
5353 wayzata blvd., ste. 400
saint louis park MN 55416
MDR Report Key19216966
MDR Text Key341437875
Report Number3027386225-2024-00032
Device Sequence Number1
Product Code LNQ
UDI-Device Identifier00763000449704
UDI-Public00763000449704
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H990014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Non-Healthcare Professional
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 04/02/2024
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
Device Operator Health Professional
Device Model Number37800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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