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

Model Number 37800

Device Problems No Device Output (1435); Device Difficult to Program or Calibrate (1496); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Complaint, Ill-Defined (2331); Malaise (2359); No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2017

Event Type  Injury  

Event Description

The patient reported that their healthcare provider had trouble turning their device on and programming their system.The patient was scheduled to see their healthcare provider on (b)(6) 2017.No symptoms were reported.There were no further complications reported/anticipated.

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.

Manufacturer Narrative

Patient code (b)(4) is no longer applicable to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the patient reported that they only checked the battery.The patient stated that they saw a healthcare provider and they told the patient the unit was not doing anything for them as they had a vagotomy in 1987.No further complications were reported.

Manufacturer Narrative

There are no product problems related to the event.Adverse events still apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the patient reported there was a confusion with what they originally reported and that the device had always been on.They just wanted to find out where they could go to get their device adjusted, monitored, and battery level checked while in another state.The patient clarified that when they were at their old hcp's office the device they used to check them was from "the stone age".It would only check whether the stimulator was good or bad and it was unable to check the device settings.When they used to see another physician the device could tell them the implant date, battery life used and what they had left, and if they changed the settings to a different higher setting to where he would feel better.The patient's current hcp office doesn't do that and it sounded like they had nothing to do with it or had no clue on what to do.The patient further reported they had been super sick for the last few weeks and stated they were going to a new gi doctor the following week.They had been in the hospital twice and the hospital had no idea what to do.They put an iv in the patient and gave them something for the nausea and vomiting.They were not familiar with the device.The patient said he asked them "to cut him up and take the device" out, but they declined.The patient stated that was their health and they were frustrated that things were not going right.They would be following up with a gi doctor from now on and would no longer see their other hcp.They confirmed they had been sick for 6 weeks.Follow up from the patient on (b)(6) 2017 reported that the patient talked to their hcp about the device not working due to their vagus nerve being clipped in a previous surgery and the hcp told them that was not correct.No further complications were reported/anticipated.

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 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: 6576538
• MDR Text Key: 75522904
• Report Number: 3004209178-2017-10591
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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,Followup,Followup
• Report Date: 08/07/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: Not provided; 06/30/2017; 07/14/2017; 07/14/2017
• Supplement Dates FDA Received: 06/26/2017; 06/30/2017; 08/07/2017; 10/04/2017
• Date Device Manufactured: 12/23/2014
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 78