MAUDE Adverse Event Report: ENTERRA MEDICAL, INC ENTERRA II IPG; GASTRIC STIMULATOR

Model Number 37800

Device Problems Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

Customer service received a phone call on the main line from the patient's mother about her daughter.Her daughter has an enterra ii.She said she called a few months ago and talked with her local sales rep was referred to someone in her area for her daughters device.Her daughters shocking is getting worse and the shocking is going into her face.This call was transferred to (b)(6) at tech support for further assistance.Patient's mother is stating experiencing worsening shocking in the stomach that has worked the way up to the patients face.Patient is reportedly experiencing a shocking sensation that they did not happen with their original enterra device, following a battery change by dr.(b)(6).They claim to be experiencing a shocking in the abdomen, back, and radiating up to their neck and face.Enterra medical inc.Recommended to go back to their managing provider to investigate shocking sensation ((b)(6), dr (b)(6)).They wanted additional implanting centers to meet with another gi for a second opinion.Next closest options were (b)(6).Enterra provided names and contact info for three options in those cities from the physician finder.As of (b)(6) 2024, they have yet to make an appointment or be seen by a physician.

• 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 Key: 18923938
• MDR Text Key: 337904786
• Report Number: 3027386225-2024-00021
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female