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

Model Number 37800

Device Problems Failure to Deliver Energy (1211); Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144)

Event Date 10/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer via a manufacture representative (rep).It was reported she hit her device accidentally with a pipe about (b)(6).The patient stated since then she had been experiencing an increase in her nausea and vomiting symptoms.The patient stated she didn't feel it at all.The patient stated she was going to see her healthcare professional (hcp) on (b)(6) to check it out.The patient stated she had an x-ray done somewhere and they said it looked normal.The rep noted it was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The rep did not know if there were any troubleshooting or diagnostics performed.The rep noted it was unknown what intervention or actions were taken to resolve the issue.The rep noted the issue was not resolved at the time of the report and the hcp did not have any further information about the event.The rep stated there was no surgical intervention and none was planned.Additional information from the rep on october 11th reported they had spoken to the hcp and she interrogated the patient¿s device and the impedances was 402 and the battery status was ok.The hcp stated they upper voltage to 8 volts and she was already on a rate of 55, on 2 seconds and off 3 seconds.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 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: 7960617
• MDR Text Key: 123840835
• Report Number: 3004209178-2018-22894
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2018

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: 04/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/12/2018
• Date Device Manufactured: 11/11/2016
• 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 Age: 54 YR