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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Twitching (2172); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554)

Event Date 10/08/2012

Event Type  Injury  

Event Description

It was reported the internal neurostimulator (ins) was defective.It was noted the patient had a shocking or jolting sensation since implant.It was reported the shocking had gotten worse over time.It was noted moving the leads and ins in (b)(6) 2013 helped the issue for four months, then shocking started and therapy was not working.It was reported the ins was turned off on (b)(6) 2014 and a temporary device was put in.It was noted the ins was turned back on and increased on (b)(6) 2014.It was reported the patient experienced vomiting, diarrhea, inability to eat, and dehydration on (b)(6) 2014.It was noted turning stimulation down resolved the vomiting.It was reported the patient thought the issue stemmed from overstimulation, but their healthcare provider disagreed.It was noted the patient felt really sick.It was reported the patient¿s ins was to be replaced as soon as possible.It was noted the patient¿s stomach was getting shocked, did a ¿funny, hard twitching,¿ then constrict and let go for extended periods of time.It was reported the patient was scheduled for replacement surgery on (b)(6) 2014.It was noted the patient was hospitalized for the vomiting and diarrhea.It was reported the patient¿s trial worked ¿awesome¿ and the implant had shocked since implant.

Manufacturer Narrative

Concomitant products: product id 435135, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2013, product type lead; product id 4351-35, serial # (b)(4), implanted: (b)(6) 2013, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was later reported that ever since the patient got their pacemaker they did not gain any weight and they had to go on a feeding tube.It was stated, the device would shock the patient and the reporter could see when the patient was getting shocked.It was noted at the (b)(6), they turned it up a little and then they had non-stop vomiting and diarrhea and lost 6 pounds in 2 days and was at a hospital.It was stated, the patient had their device and leads replaced in (b)(6) and they have been fine and had not had to touch it.It was noted that since the replacement the patient gained 8 pounds, had no episodes, and no adjustments since.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the patient's old ins malfunctioned and was giving the patient problems since the day they had it put in.The patient weighed (b)(6), had bowel obstructions, vomited all the time, had severe diarrhea, and lost 8 lbs in 3 days with the old device.Since they replaced it, the patient gained (b)(6).The patient was a normal kid now and didn't even need to take any of their medication anymore.They had to reprogram it 1 times since they put it in and it was working great.

Manufacturer Narrative

Additional information: neurostimulator (ins) (b)(4) stimulation ins functionally okay, insignificant anomalies.Lead (b)(4) no significant anomaly stim lead body cut through product segment.Lead (b)(4) no significant anomaly stim lead body cut through product segment.

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: lead.

Event Description

Additional information received reported that the cause of the event was unknown.Surgical intervention of replacement of the implantable neurostimulator (ins) and leads took place on (b)(6) 2014.It was noted that reprogramming occurred multiple times.The patient did not require hospitalization due to the event and the patient recovered without sequelae.Additional information received reported that it was not normal battery depletion and there was no patient death.

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 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: 3756778
• MDR Text Key: 4550983
• Report Number: 3004209178-2014-07417
• 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,consumer,health profess
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/27/2014

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: 11/14/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 00013 YR