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

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 09/25/2016

Event Type  malfunction  

Event Description

The consumer reported that the patient had a sudden loss of therapy and return of symptoms in (b)(6) 2016.There were no trauma or falls that could be related to the issue.The patients implantable neurostimulator (ins) turned off by itself and it had worked fantastic up until now.The patient thought it turned off because their symptoms returned.This was a sudden symptoms change and it got worse every day.The health care provider (hcp) told the patient it turned itself off and asked if the patient had traveled.The patient had traveled, but didnt think that was the cause.The return of symptoms occurred in (b)(6) and that was also when the patient traveled and went through a security gate.The patient mentioned using their tablet that had a magnetic cover that rested against their implant and they might get a non-magnetic case.The patients symptoms were getting better since visiting their hcp and they wanted to know if it was a slow process once the device had turned back to get their symptoms controlled again.The indication for use for this patient was gastric stimulation.

Manufacturer Narrative

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

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.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.It was reported they told the patient the magnetic case for her ipad ¿turned the stimulator off once¿ when they had it against their stimulator because it was in their lap.The patient stated this occurred in 2016.The patient stated she didn¿t know the stimulator was off until she went to the healthcare professional¿s (hcp) office 6 weeks later but stated that during that time her gastroparesis symptoms had returned.The patient stated once the hcp turned the stimulation back on, the symptoms eventually resolved but it was not immediate.The patient stated it take almost a year to recover from the setback from having it off.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

• 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: 6103288
• MDR Text Key: 59977257
• Report Number: 3004209178-2016-24038
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2018
• Date Device Manufactured: 09/27/2013
• 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: 72 YR
• Patient Weight: 59