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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
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/23/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Device just implanted on (b)(6) 2025 but needed to be removed due to infection.Physician called to let me know he had removed the device.Patient is a diabetic and had both legs amputated above the knee prior to having enterra implanted.Device was disposed of at facility.
 
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Brand Name
ENTERRA II IPG
Common Device Name
GASTRIC STIMULATOR
Manufacturer (Section D)
ENTERRA MEDICAL, INC.
5353 wayzata blvd., ste. 400
saint louis park MN 55416
MDR Report Key22323322
Report Number3027386225-2025-00070
Device Sequence Number8811972
Product Code LNQ
UDI-Device Identifier00763000449704
UDI-Public00763000449704
Combination Product (Y/N)N
PMA/510(K) Number
H990014
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/28/2025
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? No
Operator of Device Health Professional
Device Model Number37800
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/24/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age32 YR
Patient SexFemale
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