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

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

The consumer reported that the patient had a loss of therapy in (b)(6) 2016.The implantable neurostimulator (ins) battery had not been working for a while and the patient no longer felt stimulation.The patient experienced shocking sensations, which they felt were caused by the stimulator.A couple of days ago in (b)(6) 2016, the patient fell back on the wheelchair and may have hit their implant.The patient's family member was not sure if this would have caused the shocking or not.The shocking was related to positional movement as the pain was worse when the patient moved.The patient had shocking about every 2 minutes.The patient's family member had a call in to the patient's health care provider (hcp), but they were only there on tuesdays.They hoped to get a manufacturer representative to meet them.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 health care provider (hcp) reported that the troubleshooting performed related to the patient no longer feeling stimulation and the shocking sensation was that a programmer was employed to interrogate the unit.The action taken to resolve the patient not feeling stimulation and shocking sensation was that there was evidence of spontaneous deactivation and the hcp reactivated the unit with its former settings.

Manufacturer Narrative

Corrected information: sex, date of birth 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 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5586802
• MDR Text Key: 42991725
• Report Number: 3004209178-2016-07716
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2016

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: 09/14/2015
• 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: 03/25/2016
• Initial Date FDA Received: 04/19/2016
• Supplement Dates Manufacturer Received: Not provided; 05/12/2016
• Supplement Dates FDA Received: 05/25/2016; 09/21/2017
• Date Device Manufactured: 03/19/2014
• 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: 00064 YR