MAUDE Adverse Event Report: MEDTRONIC ENTERRA THERAPY

Device Problem High impedance (1291)

Patient Problems Gastritis (1874); Paresis (1998)

Event Date 03/13/2015

Event Type  Injury  

Event Description

Device revision due to malfunction.Dates of use: (b)(6) 2014 - (b)(6) 2015.Diagnosis or reason for use: gastroparesis.(b)(6) 2014: initial implant (b)(4) generator, (b)(4).On (b)(6) 2015: revision due to malfunction / high impedance.On (b)(6) 2016: device explant.On (b)(6) 2017: implant of new device (device info not available.).

• Brand Name: ENTERRA THERAPY
• Type of Device: ENTERRA
• Manufacturer (Section D): MEDTRONIC; 7000 central ave ne; rce250; minneapolis MN 55432 3576
• MDR Report Key: 7066827
• MDR Text Key: 93328666
• Report Number: MW5073610
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 54