MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Distress (2329); Constipation (3274)

Event Type  malfunction  

Event Description

A consumer reported that a patient's battery was not working.They were supposed to have surgery to replace the battery.The patient was on some narcotic drugs orally, due to their gastric issue.The patient was in the operating room for surgery and the healthcare provider (hcp) state that they would not do surgery due to the patient's narcotics.The hcp would not do surgery until the patient gets off narcotic drugs.The consumer stated that the patient could not get off of narcotics because they were in too much pain.They said that the patient does not eliminate for days at a time despite taking a lot of laxatives.The implantable neurostimulator (ins) was indicated for gastric stimulation.

Event Description

Additional information from the patient reported they still had not found an hcp willing to remove the device and they were still in pain.They stated the battery had run out and was not working anymore.They were still looking for a physician that would take them and remove the device.On (b)(6) 2017 the consumer further reported that the patient "is about suicidal" because they were not getting anywhere with the ins replacement.It was reviewed that the patient should get immediate medical attention if they are suicidal.The consumer then stated that they were "just using that term (suicidal)" because the patient is so frustrated with the current situation.The patient had originally found another surgeon, but was then told that surgeon could not do it.The patient was trying to get in touch with the manufacturing representative to see if there was another surgeon who would do the surgery.Rep roles were reviewed with the patient and a courtesy contact was sent to the rep.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6325229
• MDR Text Key: 67213573
• Report Number: 3004209178-2017-03658
• 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,Followup,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2006
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Date Device Manufactured: 12/21/2004
• 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