MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Paresis (1998); Vomiting (2144); Complaint, Ill-Defined (2331); Constipation (3274)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the condition the implant was supposed to help treat triggered a ¿flare up¿ or ¿episode¿ late in the evening around 11:00 pm.It was noted that the patient had the implant for gastroparesis.The patient was not ¿digesting¿ properly because they were vomiting since last night into this early morning, and they did not have a bowel movement and was aware of everything they ate.The patient went to see their primary care doctor yesterday for this and the doctor heard a ¿humming noise¿.The patient was inquiring about if there was a possibility that the implant was not working properly; they were redirected to follow up with a healthcare provider (hcp) and it was noted that the patient would.No further complications were reported/anticipated.

• Brand Name: INTESTINAL STIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7444125
• MDR Text Key: 106397790
• Report Number: 3007566237-2018-01158
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2018
• 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