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

Model Number 3116

Device Problem Ambient Noise Problem (2877)

Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.(b)(4).

Event Description

It was reported that the patient experienced a loss of therapy.She was not digesting as well after use of a therapeutic ultrasound; she had a disk issue with bone on bone in her back.The healthcare provider (hcp) decided to use ultrasound on the patient three weeks ago and she stopped going to the therapy because she felt it was affecting her stomach.She went on a liquid diet and took domperidone, which seemed to be helping her recover.The patient intended to follow-up with her hcp.No interventions or patient outcome were reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Event Description

Additional information received reported that the patient quit physical therapy and started "probonics" and domperidone.The patient was "waiting for the machine so that she could have it tested." it was not entirely clear what the patient meant by "waiting for the machine so that she could have it tested.".

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4929223
• MDR Text Key: 22589449
• Report Number: 3004209178-2015-13783
• 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
• Reporter Occupation: Other
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• Date Device Manufactured: 09/30/2011
• 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: 00055 YR