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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 03/09/2017

Event Type  malfunction  

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 that the patient had an issue with their device since surgery.They stated that their stomach would visibly contract and they had a lot of stimulation pain.It was noted that it would shoot down along where the wire was, down under the belly button, to the device.After eating or drinking anything, the patient¿s stomach was larger and they could see it contracting and they would get a sharp pain.It was also noted that, when they woke up from surgery, they were getting shocked.This was due to fluid build up around the electrodes.The patient also noted that they hadn¿t got much relief from the stimulation.It was further reported that the patient was still feeling shocks a month and a half after surgery so they turned down the stimulation.The patient was told by their doctor that it would go away after their body absorbed the fluid.The year prior to the report, the patient had an x-ray and the leads were in place.Every time the stimulation got turned up, they felt it more and they would feel it constantly for 24 hours after it was adjusted.It was noted that the patient followed-up with their doctor the day prior to the report and was going to follow-up again about the visually seeing the contracting and the stimulation pain on (b)(6) 2019.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They provided their weight at the time of the event.They stated that they had multiple adjustments, x-rays, and were currently adjusting the voltage down while increasing the rate to see if that helps.No further patient complications were reported as a result of this event.

• 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: 8561498
• MDR Text Key: 143462490
• Report Number: 3004209178-2019-08511
• 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
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Date Device Manufactured: 09/14/2016
• 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 Age: 28 YR
• Patient Weight: 66