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

Model Number 37800

Device Problem Insufficient Information (3190)

Patient Problems Vomiting (2144); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.  it was reported the patient had a loss of therapy; caller states that about 3 weeks ago the patient was having vomiting episodes, so they were hospitalized.Today the same vomiting issue has occurred and the patient may end up going to the hospital again.Caller believes that the device is no longer working ("not active") or needs to be checked on and adjusted, but the primary care physician does not have access to a clinician tablet to check this.Caller states that the patient maybe gets "sick" maybe twice a year, so they thought the first vomiting episode about 3 weeks ago was just routine, but then the patient got sick again today; asked/unknown for event date since the caller did not clarify this statement.Troubleshooting was unable to be performed but patient services reached out to the field and sent doctor listings as well.The patient was redirected to their hcp to further address the issue.No other information from that case was provided.See (b)(4) for the report of already reported events.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10420449
• MDR Text Key: 203349034
• Report Number: 3004209178-2020-14261
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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
• Report Date: 08/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 08/18/2020
• Date Device Manufactured: 07/26/2016
• 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