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

Model Number 3116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Dehydration (1807); Headache (1880); Nausea (1970); Weakness (2145); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Sleep Dysfunction (2517); Lethargy (2560)

Event Date 12/09/2016

Event Type  malfunction  

Event Description

A patient reported they had been transferred to the emergency room (er) due to weakness, nausea, lethargy, dehydration, stomach pain, and headache.They had been trying to find a healthcare professional (hcp) to see about their device since the hcp who implanted the device left their facility in (b)(6) 2015.Starting two weeks prior to the report, their pre-implant symptoms had returned and were very strong making it difficult to eat, drink fluids, sleep, work, or attend to their personal needs.The patient had been trying to make a follow up appointment but was told that their hcp had left and they were not coming back.They tried to find another hcp but could not and when their symptoms got so bad those past weeks, they made the same calls and got the same answers.They were finally able to get an appointment with a tech to at least do a reading to see if the device was even on.They were just so sick they kept calling and was told they had to see their implanting physician.They were not sure if the device was causing how sick they felt and could not get anyone who knew anything about the device to see or speak to them.They called their primary doctor and got hysterical when they told the patient they had to see a gastroenterologist because they really felt sick and wanted to see if it was anything other than the device.On friday afternoon, prior to the report and upon examination the hcp sent the patient to the er by ambulance.They had to keep telling everyone at the er that they could not call the hcp on their device card and that they had to call the manufacturer if there was an emergency with the device and to make sure they understood that they could not just call the practice their hcp had been in.No one would take the patient and they were told by the practice that they were no taking their old hcp's patients because there were a lot of them and they did not have the capacity.They found out that over 40 people had the device implanted with that hcp and they didn't know what any of them are doing or who they might have gotten to accept them as patients.They were scheduled to go in for a reading the following day and had no idea what to do if they say there was problem or if it was not working.They did not understand how there could be no one to help them find someone to take over their care.The ins indication for use was not clear at the time of the report.

Manufacturer Narrative

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.

Event Description

Additional information received from the patient reported that the circumstances that led to the reported event was nausea and vomiting when drinking fluid led to not drinking sufficient amounts of liquid, lack of md to see regarding device led to continued lack of hydration, and escalation of symptoms led to primary care md visit.Steps taken to resolve the reported event were noted as sent to emergency department, given 2 bags of fluid, rest, protein drinks, continued monitoring of water consumption, and endoscopy scheduled.With respect to the reported symptoms, it was noted that nausea and stomach pain were not resolved.

Manufacturer Narrative

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.

Event Description

See attached user facility medwatch.

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 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: 6293443
• MDR Text Key: 66273354
• Report Number: 3004209178-2017-02282
• 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,Followup,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Date Device Manufactured: 11/04/2010
• 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: 53 YR