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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Intermittent Shock/Stimulation (2287)

Patient Problem Electric Shock (2554)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

Other called the patient liaison line and left a voicemail stating, "my daughter has an implanted enterra device.She's had it in place for a week and it's sending excruciating shock to her body.She's at nationwide children's and doctor lu and doctor diefenbach have never had this happen either." i called and spoke with the mother on (b)(6) 2023 and she states she already spoke with the rep, (b)(6).She states the patient was implanted last week by dr.Diefenbach and started experiencing the shocking about 10 hours after the surgery.She states the device was turned off, it was then turned back on at a lower voltage.The patient then began experiencing the shocking and the device was turned off and is currently off.She states she had an ultrasound yesterday and there was seroma around the battery.She states they were about to go into a gi appointment with (b)(6).Discussed issue with (b)(6), and will send email to (b)(6).

• 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: 18410517
• MDR Text Key: 331534453
• Report Number: 3027386225-2023-00036
• 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: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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: 14 YR
• Patient Sex: Female