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

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that the patient was doing great and suddenly they were not feeling good; 911 was called, the patient¿s blood pressure was like a ¿yo yo¿ 210/1, and the patient had been in the hospital.It was noted that the healthcare providers (hcp) were not familiar with the implant and wanted to know if it was working and maybe the patient was having a gastric problem.The patient¿s temperature was high and a cardiologist was seeing the patient today.It was noted that they did not know if the patient¿s symptoms were related to the implant or not.No further complications were reported/anticipated.Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that the patient¿s therapy settings were increased to resolve the patient not feeling good and that their blood pressure and temperature were normal and they were being released from the hospital when the manufacturer representative got there.It was noted that cause of the patient suddenly not feeling good, their blood pressure being like a ¿yo yo¿, and their high temperature was not determined.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: 7481389
• MDR Text Key: 107170322
• Report Number: 3004209178-2018-09927
• 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: 05/02/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/02/2018
• Date Device Manufactured: 01/25/2016
• 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 Outcome(s): Hospitalization
• Patient Age: 83 YR