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

Model Number 37800

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

The patient is experiencing shocking and cannot lay on their left side without experiencing.Patient returned call for permanent implant card being returned to sender.Patient stated on the call that they are experiencing shocking problems(did not specify more) , they cannot lay on their left side.They also stated they have talked to their doctor and they do not like their doctor from university of illinois hospital dr.Mario masrur.They have been trying to find a new managing physician closer to them and that will help with the device management.The patient verified their last implant and managing doctor to get a new implant card mailed out.Patient was transferred to tech support (b)(6) for the issues they are experiencing and to locate a new doctor closer to them.

• 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: 18783192
• MDR Text Key: 336870438
• Report Number: 3027386225-2024-00017
• Device Sequence Number: 1
• Product Code: LNQ
• 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: 02/13/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• 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: 56 YR