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

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943)

Event Date 06/14/2016

Event Type  Injury  

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

The patient reported that they had been having internal itching that was worst at night for almost a year.They had been working with the healthcare provider (hcp) to determine the cause, and the hcp told them that the device may be affecting the nerve endings.The hcp mentioned that they might be inflamed or infected.It was indicated that the hcp wanted to put the patient on different nerve medications, but the patient didn't want to try the medications if they made matters worse.The patient stated that they would see the hcp mid (b)(6) 2017.It was noted that the patient mentioned "jolting," and this was clarified that the patient meant it was just the stimulation sensation.It was not uncomfortable, it was just letting them know the stimulation was there.It wasn't a concern to the patient.There were no further complications reported as a result of this event.The indication for use was gastrointestinal/pelvic floor and gastric stimulation.

Manufacturer Narrative

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

Event Description

Additional information received from the patient indicated that they just started getting up at night itching with no sign of external rash.The issue had not been resolved, but they were going to go see their doctor next week.There were no further complications reported as a result of this event.

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: 6664855
• MDR Text Key: 78343316
• Report Number: 3004209178-2017-13603
• 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
• Report Date: 07/25/2017

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: 03/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 07/21/2017; 07/21/2017
• Supplement Dates FDA Received: 07/25/2017; 10/05/2017
• Date Device Manufactured: 09/30/2011
• 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): Other
• Patient Age: 56 YR
• Patient Weight: 59