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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Chest Pain (1776); Fall (1848); Nausea (1970); Paresis (1998); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that there was a loss of therapeutic effect, symptoms returned starting (b)(6) 2013, and the patient had been in and out of the hospital.The device had been adjusted a few times but it hadn¿t helped.The symptoms came in waves but lately the symptoms were more frequent.The patient also had a sudden return of symptoms as if the machine was not working.There was a possibility of the implant malfunctioning.About five day prior, there was a lightning strike by the patient¿s house, the patient fell to the floor and felt like he was shocked, and now he was sick with gastric paresis.The patient stated that his gastric stimulator or stimulation had been acting up.The patient went to the implanting doctor on 2014-(b)(6) to check and reset the implant and a nurse practitioner did the programming.The patient was having difficulties and didn¿t think it was set right.The way it was acting right now, the patient¿s whole body was churning and it felt like something was pulsing inside his body.The other day his chest started to hurt.The patient noted that this meant the electrical impulse from the device had to be interfering with the electrical impulses with the rest of his body.The setting was 3 seconds on and 2 seconds off, and the voltage and megahertz had been ¿jacked up¿ and they were maxed out, but he didn¿t know how high they were.This time it had gotten worse and didn¿t take care of the patient¿s nausea.The issues started two days after the programming appointment because it usually took a day or two for the implantable neurostimulator (ins) to kick into the mode it was set in.The patient stated that the implanted system may die or may be damaged and he couldn¿t get anyone to check it.The patient¿s gastric doctor suggested the patient go back to the implanting hospital, have them turn the device off, and remove it immediately.The patient had not contacted his managing healthcare professional since the problems started.No additional interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant: product id 435135, serial# (b)(4), implanted: 2011-(b)(6), product type lead.Product id 435135, serial# (b)(4), implanted: 2011-(b)(6), product type lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4082440
• MDR Text Key: 4831481
• Report Number: 3004209178-2014-16882
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2014
• Date Device Manufactured: 05/03/2011
• 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): Hospitalization
• Patient Age: 00056 YR