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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Burn(s) (1757); Itching Sensation (1943); Muscle Spasm(s) (1966); Pain (1994); Scar Tissue (2060); Skin Discoloration (2074); Swelling (2091); Burning Sensation (2146); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554); Partial thickness (Second Degree) Burn (2694)

Event Date 03/28/2014

Event Type  Injury  

Event Description

It was reported that the patient had a gastric neurostimulator.The patient had a burn at the neurostimulator pocket site.The pocket site had 2nd degree burn at the ins site.The burning symptom was not present a month prior to the report.The device was constantly hurting with severe burning.The implant was on at the time of the report and the doctor had just adjusted it.The doctor thought the device caused the burn.It was further reported that 3 weeks prior to the report the patient got an electrical burn.The patient had a little blister on their stomach that itched so the patient scratched it.The next day the patient looked at it and it was brown.It looked like someone stuck a cigarette to their stomach.The patient was also having burning at the pocket site.The patient had different symptoms and pain on the right and left side.The patient was rushed to the hospital the night prior to the report and their doctor turned the device off.X-rays were taken to see if the leads were loose.The patient was getting burned and shocked and starting having burning on the skin and in the eyes.Their right side was ¿jumping all over the place¿.The patient was considering having their entire system explanted and redone.The doctor originally thought the burn looked like skin cancer but it came on too fast.The patient was having burning all around the stimulator.The patient¿s previous doctor said that the burning had nothing to do with the stimulator.The patient had a quarter inch scar and the scab had fallen off.The patient¿s doctor thought that the implant was infected but no one was giving the patient antibiotics.The patient also had a cold.The patient¿s current doctor thought that it was an electrical burn.The patient was having a lot of pain which was jumping from left to right and burning from their throat down to their stomach and onto the stimulator.The patient was also having burning on the skin and eyes.The patient took narcain and musinex 2 days prior to the report and on the day of the report.The patient was still having some intense pain for hours the night prior to the report after they turned their stimulator off.The patient had stabbing, shocking pain almost like the device was turned up all the way.The patient was also having a contraction and was trying to breathe through it.The patient noted that they had had so many problems.The patient also did not like the size of the implant since it put it right on the hip bone and rib.It was noted that toward the patient¿s belly button it was swollen, the patient had a fever, and there was an infection.It was further reported that the doctor last saw the patient on (b)(6).The patient was still experiencing severe burning and things seemed to be getting worse.One of the patient¿s doctors thought that the incision site was infected.It was unknown if a culture was taken by one of the patient¿s doctors.Additional information has been requested, but was not available as of the date of this report.If additional information is received, a follow up report will be sent.

Event Description

Additional information received reported that it was unknown what caused the electrical burn and the health care provider (hcp) doubted that it was caused by the stimulator.No testing was done on the device and no infection was found.It was noted that it was unknown what caused the shocking and burning sensation to the patient¿s skin and eyes.No interventions were planned and the patient was following up with their gastrointestinal hcp.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: 2011-(b)(6), product type lead, product id 435135, serial# (b)(4), implanted: 2011-(b)(4), product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was later reported as far as the reporter knew the patient's device was off.It was stated it was unknown if the symptoms had resolved with turning the device off and no further testing or interventions had been done.It was noted as far as they knew the patient was fine and they had not heard from them since (b)(6) 2014.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that a couple years ago, the patient had a ¿cigarette burn¿ on their stomach from the ins.The patient felt the burn from ¿from the inside out¿.It was noted that the ins impedances were checked and everything was fine.The patient didn¿t believe the healthcare provider (hcp) did a good job implanting the ins.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead; product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Due to imdrf harmonization, results, methods, and conclusion codes were updated.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; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; road 31, km. 24, hm 4; ceiba norte industrial park; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 3759322
• MDR Text Key: 4468081
• Report Number: 3004209178-2014-07504
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2018
• Date Device Manufactured: 06/07/2011
• 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): Other; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 49