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

Model Number 37800

Device Problem Premature Discharge of Battery (1057)

Patient Problem Failure of Implant (1924)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

Patient underwent revision surgery to replace ipg in (b)(6) 2024.Battery has died, patient having refractory symptoms.Needing help with prior auth approval to insurance.Transferred to tech services for rep involvement.Rep to f/u on issue.Original implant date (b)(6) 2017.

• 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: 18783759
• MDR Text Key: 337416913
• Report Number: 3027386225-2024-00016
• 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: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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; Other
• Patient Age: 55 YR