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

Model Number 37800

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 08/24/2018

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 patient.It was reported that they were experiencing terrible pains from the device, like a horrible electric sensation.The patient stated that they felt like they were being tasered.The patient mentioned that they tried calling their healthcare provider (hcp) but they were being told to go to the emergency room (er).The patient stated that they were currently at the er and didn¿t know what to do.It was noted that the electrical/tasering sensation was located in the patient¿s left abdomen.The patient stated that the issue started when they got implanted on (b)(6) 2018 and had just gotten worse.This was considered a sudden change in therapy/symptoms.It was reviewed that the patient could speak to their hcp or get in touch with a manufacturer representative to have the device checked.No further complications were reported or anticipated.Indications for use are gastric stimulation and gastrointestinal/pelvic floor.

Manufacturer Narrative

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

Event Description

Additional information from the consumer on (b)(4) reported the healthcare professional (hcp) turned off the ins and then turned it on and everything seemed better.There were no further complications that have been 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 from the consumer regarding the patient reported the shocking sensation was not as bad as it was, but especially when she laid on her side it was almost like she could make the shocking sensation happen.The patient stated she went to emergency room (er) on (b)(6).The patient stated she was admitted to the hospital for 9 days.The patient inquired if the issue could be due to a malfunction.The patient stated she was not getting any answers from her healthcare professional (hcp).There were no further complications that have been 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 consumer.It was reported that the patient saw their hcp the day prior to the report and they didn't mention anything was wrong with the unit.However, the patient stated that the spasms were still bad and this had been going on since they were implanted on (b)(6) 2018.A week prior to the report, the hcp checked the device and increased the settings.The patient noted that they felt the spasms and could see the spasms and wondered if this was normal.They saw this a hand width above the device and to the right and the more they turned up the stimulation, the worse the spasms were.Sometimes they would last a long time and other times they were very quick.It was further reported that the patient was seeing their physician on friday [(b)(6) 2018].

• 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: 7844732
• MDR Text Key: 120129951
• Report Number: 3004209178-2018-19864
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2018

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: 10/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/19/2018; 10/10/2018; 10/25/2018
• Supplement Dates FDA Received: 09/20/2018; 10/11/2018; 11/08/2018
• Date Device Manufactured: 04/16/2018
• 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: 44 YR