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

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Effects, Unexpected (2099); Malaise (2359); Electric Shock (2554)

Event Type  malfunction  

Event Description

The patient reported that they felt zap back in (b)(6) 2015.It was also noted that the device turned off two months after implant.It was also noted that the patient felt sick the past week.The patient wanted to check on battery with recall.It was noted 2 months later when they went to increase the device was off.The patient stated her hcp (healthcare provider) said there had been problems with the ins's (implantable neurostimulator ) turning themselves off.The patient stated she had looked online some labeling thing on the fda site and wanted to know if there had been any recalls.Patient services reviewed there had been no recalls on enterra.The patient was feeling effects of it being on and felt a couple zaps during this time frame and 2 months later went to hcp and it was actually off.The patient felt a zap back in (b)(6) 2015 sometime.The patient was just walking across the kitchen and she almost fell to her feet.The patient had it checked and the device was turned off somehow the hcp had stated.The patient didn't know how this was turned off.In the hospital after implant the patient had it a couple times but the nurses were notified.The patient stated she also had been feeling sick in the last week and was now questioning whether it was on or not.The patient doesn't see hcp for a couple more weeks but will call to see if can get in earlier.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).

• 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 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: 4810013
• MDR Text Key: 5835346
• Report Number: 3004209178-2015-10073
• 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
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2015
• Date Device Manufactured: 12/13/2014
• 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: 00035 YR