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

Model Number 3116

Device Problems Loss of Data (2903); Impedance Problem (2950)

Patient Problems Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 08/01/2017

Event Type  malfunction  

Event Description

A healthcare provider (hcp) reported a patient with an implantable neurostimulator (ins) had a return of their nausea and vomiting about two months prior to the report.When interrogated by the clinician programmer, it indicated the serial number was incorrect, ma was at 0.0, and impedance was showing out of range.The patient had a new device around (b)(6) 2016.The hcp said there was no verbiage showing that there had been a reset of the device.Impedance was tested and showed 601 ohms with recommended current of 3.0ma.They planned to program the patient again and would consult with another hcp.There was no known activity that prompted the event and no procedures or treatments.No further complications were reported/anticipated.

• 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: 6993964
• MDR Text Key: 91915117
• Report Number: 3004209178-2017-22942
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Date Device Manufactured: 08/29/2012
• 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 Age: 52 YR