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

Model Number 37800

Device Problems Material Puncture/Hole (1504); Material Perforation (2205)

Patient Problem Impaired Healing (2378)

Event Date 11/22/2023

Event Type  malfunction  

Event Description

Patient (b)(6) was at (b)(6) hospital in (b)(6) for a battery change of her item number 3116 which was implanted on (b)(6) 2014.I checked her device before implant and noticed that the impedance of the system was over 800ohms.We were hoping by connecting the leads of her system into a new device, that the impedance issue would normalize and that her leads would not need to be explanted.After opening connecting her leads to a new 37800 enterra ii stimulator, the impedance reading was over 20000.Next step decided by dr.(b)(6) was to remove the existing leads and replace them with a set of new leads.During the process of removing the electrodes from the surface of the stomach, the stomach perforated with an opening to the inside.As a result of a hole being created in the wall of the stomach, dr.(b)(6) decided to repair the hole and allow the patient to heal for a few weeks before replacing the enterra system.

• 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
• Manufacturer Contact: jane mammen ; 6513342011
• MDR Report Key: 18222287
• MDR Text Key: 330560145
• Report Number: 3027386225-2023-00020
• 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: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White