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

Model Number 3116

Device Problem Premature Discharge of Battery (1057)

Patient Problems Pain (1994); Paresis (1998); Weakness (2145); Complaint, Ill-Defined (2331); Malaise (2359); Choking (2464)

Event Date 10/03/2013

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.

Event Description

The consumer and health care provider (hcp) reported that the patient had digestive issues and botox and merinol did not work for the patient.The patient had suffered from the after effect of the gastroparesis.The patient was a lot better off than they were before the implant.The patient had acid reflux and felt like everything was coming up like they were choking.The patient needed a hcp to turn up the stimulator.The patient was suffering from parkinson¿s disease and all the medication that the patient was on caused it.The patient was sick.The consumer later reported that they had not sought additional intervention with the hcp.The patient's condition was exactly the same as when they called in on (b)(6) 2015.The acid reflux started after the device was implanted.The patient went to see their surgery on (b)(6) 2016 for their 6 month visit.The patient had not been feeling too good and had never felt too good.The patient had no strength and was always in pain, but had been eating.The nurse went to adjust the stimulator and the patient was told the stimulator was not working and had died.The patient was told the stimulator was good for 5 to 10 ye ars, but the patient had had the stimulator for only 2 and a half years.They did not know when this happened because the patient had been eating.The hcp told the patient they had to do a swallow test to see how fast the patient digested food.The patient wanted to know if the manufacturer could contact the imaging center and let them know this was an emergency so they could schedule the appointment to see the patient ¿stat¿ because they were elderly and had everything wrong with them.If they did not follow-up and let it go, the patient was going to die.The patient¿s stimulator voltage was set at 10.0 since (b)(6) 2014 for almost a year.The patient had other co-morbidities, including having increased mucus in their throat, diabetes, dizziness, anxiety, diverticulitis, depression, and hypertension.The actions taken to resolve the patient¿s issues were frequent changes to stimulation settings every 2 weeks and increasing proton-pump inhibitor (ppi) to twice a day.The patient did not complain of pain during any visit.The patient saw various hcps for other issues including gerd, cardiac, parkinson¿s disease was diagnosed in 2014, and the pain complaint was before the implant and a kidneys, ureters, and bladder (kub) x-ray was done in (b)(6) 2013.The patient¿s nausea was controlled, they denied vomiting, and they complained of gerd in which the patient was seeing their gastrointestinal hcp for.The patient¿s current weight was the highest weight and the lowest weight was 4 months before the patient was diagnosed with parkinson¿s.The explant date was to be determined.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.

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: 5659494
• MDR Text Key: 45305716
• Report Number: 3004209178-2016-09613
• 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
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Date Device Manufactured: 08/21/2013
• 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: 78 YR