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

Model Number 3116

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Eructate (1839); Nausea (1970); Vomiting (2144); Constipation (3274)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial #: (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 435135, serial #: (b)(4), implanted: (b)(6) 2012, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 30-mar-2014, udi#: (b)(4).Product id: 435135, serial/lot #: (b)(4), ubd: 16-apr-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient was experiencing nausea, vomiting, and constipation.The patient was also complaining of bad burps.The hcp did an esophagogastroduodenoscopy (egd) and found one of the leads had eroded into the stomach.It was noted the patient had been in jail during this ordeal.The hcp was going to remove the system on (b)(6) 2018.The rep stated it was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.It was noted the issue was not resolved at the time of the report.The patient was listed as alive with no injury at the time of the report.Additional information from the rep on (b)(6) reported the issue had not resolved.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information from the manufacture representative (rep) on (b)(4) reported the healthcare professional (hcp) removed it on (b)(4) and they had the implant to send back.There were no further complications that have been reported as a result of thisevent.

Manufacturer Narrative

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

Event Description

Additional information from the healthcare professional (hcp) reported they did not have the serial number of the device.The hcp noted all the devices were removed and the patient had recovered.There were no further complications that have been reported as a result of this event.

• 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: 8137661
• MDR Text Key: 129489440
• Report Number: 3004209178-2018-27019
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2019

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: 10/28/2013
• 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: 11/28/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 12/08/2018; 02/11/2019
• Supplement Dates FDA Received: 12/14/2018; 03/04/2019
• Date Device Manufactured: 05/03/2012
• 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): Life Threatening; Required Intervention
• Patient Age: 24 YR
• Patient Weight: 98