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

Model Number 3116

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

Patient Problems Fall (1848); Nausea (1970)

Event Type  Injury  

Event Description

It was reported that the patient is on their third device in three years.It was noted that the devices were replaced due to normal battery depletion.However, the patient reportedly was disappointed with how long the batteries lasted.It was noted that the patient¿s symptoms of nausea with gastroparesis and nausea with headaches were so severe that their health care provider (hcp) would turn up the numbers to try and control the nausea and would use up all the batteries.It was noted that the patient had their stimulation set up at 8 or 9.It was further noted that the patient had such severe migraines that they were working with a specialist.The patient was reportedly trying a lot of different treatments including botox injections in her head and lots of different medications.It was also noted that the patient had been having migraines for 15 years and that it did not happen as a result of getting the device.The patient reportedly had vestibular migraines that caused vertigo symptoms which made her dizzy.The patient reportedly had not driven a car in over a year because, she had fallen a lot.It was noted that the patient had fallen 4 or 5 times last year.The patient reportedly would see her health care provider (hcp) every 3 months to have all the settings checked.It was noted that the nausea had been going on since the device was implanted 3 and a half years ago.It was further noted that the patient was 85% better having the device then they were before.It was later reported that on 2013 (b)(6), the patient had a programming session impedances were ¿???¿ and battery status was ok.It was also noted that impedances were greater than 4000 on several electrode pairs.The patient had another session on 2013 (b)(6) and battery status was ok and there were several pairs of electrodes with impedances greater than 4000.The patient had their device replaced replacement on 2013 (b)(6).A subcutaneous pocket was reportedly made that was a little more inferior and medial so that the generator would not hit the ribs.It was noted that the replacement device was implanted and programmed to the desired settings and turned on.The patient reportedly tolerated the procedure well and there were no complications.

Manufacturer Narrative

Product id 435135, serial# (b)(4), implanted: 2010 (b)(6); product type lead product id 435135, serial# (b)(4), implanted: 2010 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was noted that this device was implant in (b)(6) 2012 and it was dead by (b)(6) 2013.The patient thought her devices went dead because of her increasing settings for her symptoms.The patient settings needed to be higher.It was noted that patient rate was at 24.The patient was having severe migraines and it was hard to tell if she was getting nausea because of the migraine or the gastroperisis.Nausea was the patient铠worse symptom.

• 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: 3714584
• MDR Text Key: 17567904
• Report Number: 3004209178-2014-05329
• 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: 03/07/2014

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: 05/28/2013
• 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: 06/03/2015
• Initial Date FDA Received: 03/31/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/21/2015; 06/05/2015
• Date Device Manufactured: 12/05/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 00062 YR