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

Model Number 3116

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Headache (1880); Device Overstimulation of Tissue (1991); Weakness (2145); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554); Ptosis (2620)

Event Date 09/17/2018

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 regarding a patient.It was reported that the patient had an adjustment on (b)(6) 2018 and afterwards they were feeling the settings up too high and could feel that it went off, like it was shocking them.The consumer stated that the patient was used to that because it would happen every time they were adjusted.However, the consumer reported that the patient was getting more severe than normal and was getting sicker.On (b)(6) 2018, the patient woke up with their right eye and right lip drooping.The patient went to the hospital and they said that the patient could have had a stroke, but they didn¿t know because they couldn¿t do an mri.The consumer wanted to know if this was because stimulation was too high or not and it was advised that they speak with a healthcare provider (hcp).The consumer stated that the patient was getting weak and sick from malnutrition because of the gastroparesis.Since the adjustment, the patient was getting sicker.It was also reported that the patient had a migraine and the hcp was wondering whether the stimulation was causing that.The consumer stated that they wanted someone to turn down the stimulation.It was noted that the patient currently was not in the hospital but was getting brought back there as they were getting worse and worse.No further complications were reported or anticipated.Indication for use is gastrointestinal/pelvic floor.

• 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: 7919326
• MDR Text Key: 123523369
• Report Number: 3004209178-2018-21825
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2018
• Date Device Manufactured: 05/22/2014
• 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: 29 YR