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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Device Operates Differently Than Expected (2913)

Patient Problems Pyrosis/Heartburn (1883); Nausea (1970); Pain (1994); Paresis (1998); Scar Tissue (2060); Swelling (2091); Vomiting (2144); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Weight Changes (2607)

Event Date 01/01/2010

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 435150, serial# (b)(4), implanted: (b)(6) 2005, product type: lead.Product id: 435150, serial# (b)(4), implanted: (b)(6) 2005, product type lead.(b)(4) pertain to product id: 3116, serial# (b)(4), product type: implantable electrical stimulator.(b)(4) pertains to product id: 435150, serial# (b)(4), product type: lead.And product id: 435150, serial# (b)(4), product type: lead.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 yesterday, the patient started to have a really weird/odd sensation that was very uncomfortable 2 inches above/surrounding their implant in their chest that felt like heartburn and goes up over their shoulder, down their shoulder blade on their left side and the pain goes to the center of their chest.The patient called a nurse and due to where the ins was placed, healthcare professionals (hcp) thought the patient had a cardiac issue when the patient didn¿t.An x-ray and ct scan were done for the sensation that was going on, but they were not seeing a whole lot.It was noted that the patient was in the er yesterday and this morning.The patient was rear ended in a car accident in 2010 and due to the location of the implant, every time they wore a seat belt, it was over the implant.It was noted the patient could make the implant move so that it juts out of their chest.Additional information was received on (b)(6) 2018.The patient was too sick to drive out of state to see an hcp and things with their gastroparesis had not been this way for quite some time.The patient¿s pcp was able to tell on the ct scan that the implant had shifted down.It was noted that the patient¿s uterus was very enlarged and swollen so it was putting pressure up on their stomach, pushing the base of their stomach up; the stomach was putting pressure on the patient¿s vagus nerve, and was making ¿all kind of haywire¿ in there and making things uncomfortable and the patient¿s ¿innards¿ probably were not in the same place as they were 10 years ago.The patient¿s hcp told them since everything was being pushed up, things/shifted enough (device components ¿ lead and implant) were being moved around.It was noted the patient had had 4 c-sections, the last one being an emergency c-section, so the scar tissue could have also contributed to the whole uterus situation.It was also noted that the patient was diagnosed with type 1 diabetes at age 1 and had to get a root canal so that abscesses would not burst.The patient would continue working with their pcp to see if removing the implant was the best option, and from there, would find a general surgeon to remove the implant.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that what was going on had nothing to do with the car accident in 2010.It was noted that the patient¿s uterus was enlarged/swollen due to the car accident, but the problems now were not back in 2010.It was reported that what could be going on was that the enlarged uterus could be putting pressure on the vagus nerve, causing increased nausea/vomiting, but nothing had been confirmed and there had only been one scan and no other testing done.It was noted the pacemaker was almost in the patient¿s boob right now and if you looked at the scar vs.The pacemaker, it appeared to have shifted down, but they had not confirmed this.The patient was not sure if the pacemaker had moved, but they are able to see it popping through the skin and it moves in the pocket if the patient palpitated it.It was noted that it had not been functional for 10 years and the patient wondered if they start to break down because it had not been functioning for 10 years, but the patient thought it was safe to keep it implanted.It was noted that the patient had lost weight, fluctuated over the 9 years of pregnancy, but never really noticed the placement changed.The patient didn¿t think the car accident in 2010 did anything to the pacemaker and they had been in pretty good control of the gastroparesis, but was just wondering why all of a sudden they had nausea, vomiting, and pain around the pocket.No further complications were reported/anticipated.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7267695
• MDR Text Key: 100060389
• Report Number: 3004209178-2018-03222
• 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
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2008
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Date Device Manufactured: 05/15/2007
• 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 Age: 34 YR