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

Model Number 37800

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Muscle Weakness (1967)

Event Date 08/30/2023

Event Type  malfunction  

Event Description

Patient was implanted with enterra therapy on (b)(6) 2023.She called patient liaison stating she needs to have an mri.She states she has gradually developed left sided weakness since the implant surgery, including the left leg, left arm, and face.Patient did not state an approximate date of these symptoms but states it started gradually after implant surgery.Patient states it started with vibrations at the back of her head, then started having left arm pain, and trouble walking.Patient had questions about mri.I reviewed with her "certain enterra therapy devices are approved with mr conditional labeling.If you are eligible for mr conditional labeling, you can have an mri scan of some body parts under certain conditions.These body parts include head, upper, and lower extremities.Your physician or healthcare provider will determine if you are eligible for an mri." i encouraged her to reach back out to her enterra therapy provider to determine if she was eligible for an mri and emailed her the mri guidelines patient guide.

• 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: 18365514
• MDR Text Key: 331324421
• Report Number: 3027386225-2023-00028
• 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: 12/12/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• 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: 29 YR
• Patient Sex: Female