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

Model Number 37800

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Vomiting (2144)

Event Date 04/01/2017

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

A consumer reported on behalf of a patient with an implantable neurostimulator indicated for gastrointestinal/pelvic floor.They stated that there was a revision on (b)(6) 2017.In (b)(6) 2017, it was found that the leads were "misfiring" and it was "firing way higher than it should have been".At that time, they stopped using the affected lead and changed to use the other lead.The patient then had a return of symptoms in (b)(6) 2017.They began throwing up and they were in pain.At the beginning of (b)(6) 2017, they went to see their healthcare provider (hcp) again and they speculated that time that the lead had either become disconnected or head eroded through the stomach wall.The hcp then turned off the device and scheduled a replacement surgery.During the surgery, it was found that there were no issues with the leads, so only the ins was replaced.When the two old leads were connected to the new ins, the system was functioning fine.The hcp told the patient and the consumer that the ins was "fried" and asked them if the patient had been around any significant sources of emi.The consumer stated that the patient had been around a state of the art electric wheelchair with a "nf22" battery and wondered if that could affect the device.It was reviewed that it would be unexpected.The patient had been around the wheelchair since 2016 and they were unsure if it was a significant emi source.No further complications were reported/anticipated.

• 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: 6869407
• MDR Text Key: 86335371
• Report Number: 3004209178-2017-19442
• 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
• Report Date: 09/15/2017

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: 05/28/2017
• 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: 09/11/2017
• Initial Date FDA Received: 09/15/2017
• Date Device Manufactured: 12/02/2015
• 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): Required Intervention
• Patient Age: 20 YR