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

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395)

Patient Problems Pocket Erosion (2013); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Abdominal Distention (2601)

Event Type  Injury  

Event Description

It was reported that the patient states stimulator was depleted and verified to not be working.The patient had nausea.The patient has a gastric pace maker currently implanted and the battery was dead.The patient has been to the surgeon office who needs to replace the battery as well as move the generator because, it had migrated out of the pocket that it was put in and it was started to push through the skin.They have put it though the patient health insurance and they have not heard anything back and the patient was getting sicker and starting to vomit.It was noted that the battery died sometime in the couple of weeks.They are not sure.The patient states it must have died the past couple of weeks because, the patient was stating to swell up really big.Their stomach was very extended and a lot of nausea and vomiting the patient didn't feel like that when it was working and they verified the stimulator was dead.The patient went to the surgeons office that put in the battery last thursday (b)(6) 2014 and they sent the patient down stairs.It was verified that the stimulator was dead and not only that but it had come out of place and was threatening to come through the skin.The patient has the return of symptoms about 1.5-2 weeks.The patient states, the healthcare provider feels the stimulator depleted due to normal battery depletion.The office sent the notes of the visit and the letter stating the stimulator needed to be replaced and states it was sent to manufacturer company who was working with the patient health insurance to get it trial approval for the new stimulator and have it moved back in place.It was taking them a long time and the patient was getting sicker.The patient was told to call the insurance company and they told her they can¿t provide them any information.They told her to call manufacturer company and manufacturer company could call the provider line and that could tell that exactly what step they were at possible move things along.They told the patient if they needs to be seen to go to the hospital though the er (emergency room) and would have to wait and still would have to wait but told the patient it may go faster because, the patient was the inpatient.The patient wants to move it along because, they were getting worse and worse.The patient notes that the stimulator was approved 2 times already.The first was for the original implant over 10 years ago when their stomach stopped emptying and the 2nd time in 2006.The patient states both were replaced due to normal battery depletion.The patient was told the first implanted should last 3-6 years and it lasted 3 years.The one in now they had for a little over 7 years.The healthcare provider told the patient he has not seen it go over 7 years.It was noted that the patient couldn¿t schedule the surgery until they received the approval from insurance company.Additional information received reported that the patient had no stimulation sensation.It was noted that the patient was still waiting on approval from health insurance company.The caller states, the patient has had the device for about 12 years and it was clarified further.The caller was asked how many battery changes did the patient have and was one after 2006? the caller states, the patient has had two battery changes which were what the system reflects and states the patient needs a battery change now and that¿s what the caller was calling about.The caller states they went to see healthcare provider on (b)(6) 2014 and the battery was dead and the patient has symptoms of stomach was huge, nausea and vomiting, absolutely miserable.The caller states they have had to take the patient to the emergency room to have the patient stomach decompressed and doesn¿t understand why it was taking so long.The caller states they took the patient to the er (emergency room) on (b)(6) 2014.

Manufacturer Narrative

Product id 435135, serial# (b)(4), implanted: 2004 (b)(6); product type lead product id 435135, serial# (b)(4), implanted: 2004(b)(6); product type lead.(b)(6).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the event was due to battery depletion and was replaced.Nausea was the symptom associated with the event.It was unknown if hospitalization was required and no injury reported.

• 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: 3757238
• MDR Text Key: 4468558
• Report Number: 3004209178-2014-07452
• 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
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2007
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2014
• Date Device Manufactured: 03/29/2006
• 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: 00036 YR