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

Model Number 37800

Device Problems Pocket Stimulation (1463); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Foreign Body Reaction (1868); Headache (1880); Undesired Nerve Stimulation (1980); Malaise (2359); Loss of consciousness (2418); Diaphoresis (2452); Insufficient Information (4580)

Event Date 01/31/2022

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown gastric indications for use.It was reported that the reason for the call was that the patient had some complications from their (b)(6) 2021 implant.This was clarified to mean that on (b)(6) 2022, the implant "overcharged itself." further clarification as to what this meant was asked, and the patient explained they had gotten a "real sharp pain" in their stomach where their stimulator was vibrating, and then they got a "real sharp pain" in their head and they blacked out.The patient reported when they woke up, they were soaking wet from sweating.They saw their healthcare provider  (hcp) on (b)(6) 2022, and that was when the hcp had told the patient the implanted device had "overcharged itself," and that this was "normal" at the rate the patient had their implant set to.The patient stated the hcp had told them the device "overcharging itself" could be known to happen, and that as it only happened once, the patient should not worry about it.The patient stated that in all the years they had the enterra device, this had never happened for them until january 31st.The patient stated that their previous hcp had retired, so they were seeing a pa (physician assistant).No further action was taken by the manufacturer help line.  additional information was received from the patient.They called back repeating information previously reported, and referenced the file's form number.They stated they did not know how to fill out this form due to the status of their clinic.The patient further clarified the doctor that was treating them at a gastroenterology clinic retired on (b)(6)2021.They stated now they were being treated by a pa (physician assistant) and a nurse practitioner (np), but stated they could not give the address and phone number of the clinic because the clinic was moving sometime between now and the end of may.The patient also stated due to this they could not make an appointment with the clinic.They stated they would be seeing an np that knew a lot about the gastric stimulator, but that they could not provide contact information for the np due to the clinic moving.The patient provided the following questions/answers from the form referenced: "please clarify the statement your device overcharged itself.Was there a device concern/therapy issue, procedure use issue, and so forth (i.E.Overstimulation)? it wasn't overstimulation but it only happened one time and the np and pa that i saw thought if it only happened one time not to worry about it, but it did overcharge." they also provided the following question/answer from the form: "what most likely caused or contributed to the issue? they don't know." the patient reported, "right now my stomach isn't really working because my body is not accepting the new stimulator and they said not to do anything about it or whatever for a good four months, which is the end of may." the role of the manufacturer help line was reviewed, and they were redirected to an hcp to address this issue.The patient also reported they were not feeling good.They stated they would fill out the form to the best of their ability.The information the patient provided was unable to be clarified due to the nature of the call and the patient disconnecting.The returned form was received four days later.The patient reported "unknown," in response to a question asking them to clarify the statement their device had "overcharged" itself.It was unknown if there was a device concern, therapy issue, procedure/use issue, etc.The cause of this issue and the stimulator vibrating was unknown.It was unknown if these issues were resolved.It was unknown if the blacking out was caused by or related to the device, therapy, and/or implant procedure.It was unknown if this issue was resolved.It was unknown if the sharp pain in their stomach and head had been resolved.They marked both "no," and "unknown" in response to a question asking if they had any changes in medication that could be associated with a loss of consciousness.The device was reportedly assessed by a clinician or manufacturer representative following the event, however, no response was given to the question asking for the type and results of the assessment.The patient reported they had not had any additional episodes of "sharp pain in their stomach and head, after which they blacked out." they marked both "still in use," and "unknown" for the status of their device.

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 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13810566
• MDR Text Key: 287425958
• Report Number: 3004209178-2022-03453
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2022
• Date Device Manufactured: 10/11/2021
• 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: 75 YR
• Patient Sex: Female