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

Model Number 37800

Device Problem Unintended Collision (1429)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 06/26/2015

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 patient with an implantable neurostimulator (ins) for the treatment of gastrointestinal/pelvic floor and gastric stimulation.It was reported that the patient has been consistently losing weight since implant.They stated that in the last couple of weeks they had lost a ton of weight.They also stated they were hurting when walking around.They reported the ins was sticking out of their gut and it hurt.The patient stated they saw their healthcare professional (hcp) the previous day and they told the patient to get spandex shorts to hold the device in.They stated their intestines on the right side are ¿killing them¿.They also inquired about things they can and cannot eat so that they were not in pain.The patient stated they had a fall on (b)(6) 2019 on the left side and the ins is on the right side.The patient was redirected to their hcp.No further patient complications were reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the patient had lost (b)(6).No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the circumstances that led to the fall, pain, and weight loss was that the patient¿s doctor did not give the patient a list of what they could and could not eat.It was noted that nothing was done to resolve the fall, pain, and weight loss.The pain was noted to have been due to the patient¿s gallbladder and the pacemaker had to be turned down to alleviate the pain.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: 8515232
• MDR Text Key: 141969068
• Report Number: 3004209178-2019-07400
• 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,Followup,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2019
• Date Device Manufactured: 11/16/2016
• 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: 55 YR
• Patient Weight: 54