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 Nausea (1970); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 12/21/2018

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.It was reported the patient was in the hospital due to a severe flare up she had for the last 3 weeks.The patient stated she couldn¿t eat anything for 2 weeks and was without fluids for 4 days when she went to the hospital.The patient stated she had a nasojejunal (nj) tube put in her nose while at the hospital.The patient stated the healthcare professional (hcp) at the hospital received a clinician programmer but he had no idea how to impedances.The patient noted the issue began around (b)(6) 2018.Additional information from the hcp reported the patient¿s device was at 5.2 volts, 330 pulse width, 28 hz, 1 sec on 4 sec off, the battery was ok, 1145, 99% use, contact 2 was at 335 ohms, contact 3 was at 385 ohms, and 2 and 3 were at 514 ohms.The patient was programmed to 2 3.Technical services reviewed with the hcp that based on the impedance check the system was working properly.Technical services reviewed with the hcp that a good range was 400-800 ohms.Technical services redirected the patient to the hcp to further decide how to address their nausea and vomiting.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: 8267865
• MDR Text Key: 133760277
• Report Number: 3004209178-2019-01452
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/22/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/22/2019
• Date Device Manufactured: 06/01/2016
• 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: 40 YR