MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Hernia (2240)

Event Date 11/17/2014

Event Type  Injury  

Event Description

A healthcare provider for a clinical study reported via a manufacturing representative that the implantable neurostimulator was ¿laying loose.¿ an ultrasound was performed and a small hernia cicatricalis was found.It was noted the stimulation was turned off/discontinued and the patient had medication therapy.The patient was hospitalized and the device/lead was repositioned.It was noted the device was explanted and replaced.The event was assessed as serious/severe and related to the procedure.The event resolved on (b)(6) 2015.Medical history included epicondylitis lateralis, osteoarthritis, vitamin d deficiency, and obesity.

Manufacturer Narrative

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

• Brand Name: ENTERRA
• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6409503
• MDR Text Key: 70099264
• Report Number: 3007566237-2017-01006
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

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: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: 02/23/2017
• Supplement Dates FDA Received: 10/02/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 96