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

Model Number 3116

Device Problems Intermittent Continuity (1121); High impedance (1291); Low impedance (2285); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2015

Event Type  Injury  

Event Description

The consumer and a health care provider (hcp) via a manufacturer representative reported that the patient had been experiencing major problems with their stimulator since (b)(6) 2015.The manufacturer representative had stopped by the hospital to meet the patient and said that the current and voltage were not matching up for what settings the patient had on the stimulator.They stated something was wrong with the stimulator and it was defective.The patient had been going back and forth to the hospital about this issue.The implantable neurostimulator (ins) had turned itself off somehow at some point.They thought the ins could have been possibly turned off with a magnet from a phone case, but thought that was unlikely because the magnet was so small.The battery was turning on and off and the impedance was moving high and low between interrogations.The patient would have an appointment with their hcp on (b)(6) 2016.The indication for use for this patient was gastric stimulation.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative reported that they were first aware of the patient's battery turning on and off and the impedances moving high and low on (b)(6) 2016.The actions taken to resolve the battery turning on and off and the impedances moving high and low were that they checked the battery a few times and the impedance changed.The cause of the battery turning on and off and the impedances moving high and low was not determined.

Event Description

Additional information received from the consumer and manufacturer representative reported that the patient had problems and their hcp deemed the stimulator defective and the patient wanted to have it replaced.The device settings were being changed and the device was turning on and off between programming settings.The patient¿s hemoglobin levels were down to a 9 and there was a concern there might be some internal bleeding.The patient was sick and very frustrated and couldn¿t eat, or drink, or live a normal life.The patient was at their hcp¿s office on (b)(6) 2016 and during interrogation the ins turned on and off.The patient also met with a surgeon, but they didn¿t want to move forward without meeting with both the hcp and the manufacturer representative.The patient mentioned their first ins was amazing and worked perfectly.The manufacturer representative further reported that the device was going to be replaced.

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; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5570968
• MDR Text Key: 42442088
• Report Number: 3004209178-2016-07275
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/31/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 05/06/2016
• Supplement Dates FDA Received: 05/04/2016; 05/31/2016; 09/21/2017
• Date Device Manufactured: 05/22/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00041 YR