MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems Connection Problem (2900); Positioning Problem (3009); Noise, Audible (3273)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Rash (2033); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A consumer reported that a patient was lying in bed napping, and they heard the "pacer" beep three times and was now feeling weird.The patient had an enema the morning of the report and they didn't know if that had set something off.The patient was also in urgent care the night prior to the report due to a rash called petechiae, where the blood vessels are bleeding under the skin.The home care nurse said they were not concerned about it.When they took the patient to the urgent care, they said that one of their levels was off, but the other was fine and instructed them to follow up with their primary care provider.The consumer further reported that the device had not helped the patient at all.The surgery was rough and they had to stop for 10 minutes because their blood pressure dropped so low.They had to pump the patient with a lot of fluids and after 10 minutes the anesthesiologist let them continue.The surgeon had a hard time connecting the device too because the patient was so frail and had lost so much weight.They had to make a couple of incisions to find a place to attach the leads.The patient was originally (b)(6) lbs and had lost about 30 lbs, prior to the implant, and was (b)(6) lbs.They put in a peripheral inserted catheter (pic) line after the device was implanted because of the patient's nutrition.The consumer continued to stated that the device has made the patient worse.They turned up the stimulation to 5 a week later because the patient was in such bad condition.The new setting still had not kicked in to the help them.The patient's nausea and vomiting were as bad, if not worse.The stimulation was going to be turned up the monday following the report.

Manufacturer Narrative

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

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 they thought it was beeping, but it was actually something on the tv; now the stimulator was working and the patient was getting nutrients.It was noted that after the device was turned up to 5, the patient was still doing a little, but not much; the voltage was increased again, which made the device work and the patient was actually getting nutrients so their eye sight had been restored (it was noted the patient had been blind for 4 years pre-existing to the implant).The pic line was not related to the device and was more for water/nutrients, and now the patient had a j-tube to replace the pic line, which was also not related to the device.It was noted the j-tube did pulse and caused pain, so the patient¿s mom wanted it removed.The patient started having seizures/passing out related to heart issues and the patient¿s mom was not sure if these were correlated as they started since the device was implanted.The patient¿s mom did not have anymore information/follow-up hcps as they had seen a number of providers.No further complications were reported/anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 7157242
• MDR Text Key: 96150580
• Report Number: 3004209178-2018-00048
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2018
• Date Device Manufactured: 08/29/2017
• 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): Other
• Patient Age: 21 YR
• Patient Weight: 29