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

Model Number 37800

Device Problem Battery Problem: Low Impedance (2973)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

Dr (b)(6) replaced a stimulator battery on a patient, and impedance reading revealed there was a short circuit, and the leads will need to be revised.Patient was advised that their gastric stimulator would be performing suboptimally until their leads were replaced, and to follow up with uofl gi motility team for scheduling the revision procedure.Patient was implanted with a new gastric stimulator battery, but 8840 programmer revealed an impedance below 200, or a "short circuit".Patient was informed that their gastric stimulator system would not be working effectively until the leads were fixed, and they were instructed to follow up with their managing g.I.To schedule a revision procedure.

• 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: 18922853
• MDR Text Key: 337888891
• Report Number: 3027386225-2024-00022
• 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

• 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: 03/18/2024
• 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: 55 YR