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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Electric Shock (2554); Abdominal Distention (2601)

Event Date 04/01/2019

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 regarding a patient with an implantable neurostimulator (ins) for the treatment of gastrointestinal/pelvic floor and gastric stimulation.It was reported that after the patient¿s ins was replaced ¿everything was going pretty well¿.The consumer stated the patient then started experiencing pain along their left side where the ins was, around towards their stomach and surrounding their j-tube.The consumer stated the gastrointestinal (gi) doctor turned the ins off.After about a week the pain went away.They stated because the ins was off, the patient¿s nausea went ¿through the roof¿.They stated they turned the ins back on with a lower voltage and frequency.This helped shortly but the pain started ¿going up again¿.About a week and a half later, ¿they lowered both settings again¿.The consumer stated the patient wen to the er because the pain was so high and they turned the ins off.The pain did not go away immediately but the nausea ¿went up quickly¿.The surgeon turned it back on at a lower setting.The surgeon did not think it was the ins that was ¿shocking¿ the patient because the ins was turned on at 11:30am and the pain was down considerably when the gi doctor came to see the patient at 5pm.The consumer stated the pain gradually gets worse over the course of weeks to a point where they ¿can¿t control it, even if they have pain meds¿.When the ins is turned off, it takes 24-48 hours for the pain to subside.The patient is currently in the hospital.The consumer was redirected to a healthcare professional (hcp) to address the symptoms.No further patient complications were reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the patient had an appointment on (b)(6) 2019 and complained they could not tolerate their feeding tube, along with increased stomach distention, pain along the left side of their body, and shocking pain around their battery.The issue was not resolved at the time of the report.

Event Description

Additional information received from the patient.Patient is still dealing with a shocking sensation.The doctor reached out to see what else she might do.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 8772130
• MDR Text Key: 151736099
• Report Number: 3004209178-2019-13152
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 03/28/2022
• Supplement Dates FDA Received: 12/13/2019; 04/18/2022
• Date Device Manufactured: 01/04/2019
• 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
• Patient Age: 43 YR
• Patient Sex: Female