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

Model Number 37800

Device Problems Unintended Collision (1429); Energy Output Problem (1431)

Patient Problems Paresis (1998); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 07/26/2018

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 regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that the patient¿s gastroparesis was ¿really bad right now¿ and the patient did not have the physical strength to drive 2 hours to their healthcare provider (hcp).It was noted that the patient was in a really bad auto accident on (b)(6) where the airbag in their car did not deploy, so the patient hit their abdomen on the steering wheel and the force of impact caused ¿severe abdominal trauma¿ according to the implanting hcp.Since the accident, the patient¿s condition ¿went downhill¿.It was noted that the patient was severely anorexic and may get a feeding tube, and thought that if they got a feeding tube and their stomach ¿gets left alone for some time to heal, the nerves could get better¿ and the patient could drink a liquid diet rather than gatorade.It was reported that the patient was happy with the therapy and that the therapy ¿cut down on the amount of vomiting¿ the patient had to do.The patient inquired about a manufacturer representative coming to the patient¿s location to shut the ins off for tests and turn it back on following the tests, and the patient was redirected to follow up with their hcp and that the hcp could page a manufacturer representative to assist with the patient¿s device.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: 8318096
• MDR Text Key: 136013134
• Report Number: 3004209178-2019-02672
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Date Device Manufactured: 07/06/2017
• 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