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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Muscle Weakness (1967); Paresis (1998); Burning Sensation (2146); Complaint, Ill-Defined (2331); Malaise (2359); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that in (b)(6) 2014, a patient was complaining about something on the lower right of her abdomen, but she ¿brushed it off.¿ the patient had had falls or trauma, but the device was checked via x-ray and she was advised that everything looked fine.The device was checked by someone who was not really familiar with it.Four days prior to the report, the patient had a shocking sensation in her abdomen.It was continually getting worse and brought her ¿to her knees.¿ the patient woke up every two hours at night because of the shocking.The patient had severe abdominal shocking pain for three days, starting on (b)(6) 2015 and ending on (b)(6) 2015, with the last day having the worst pain.It was comparable to labor contractions.The patient drank fluids, had a soft diet, stayed in bed, and tried not to move.The symptoms stopped on their own.The patient was planning to go to a doctor in another state to have the device checked and get well.It was unknown if there was 50 percent or greater symptom reduction, if reprogramming was needed, if there was a loss of therapeutic effect, or if there was a loss of stimulation.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient reported that she had been admitted to the hospital and was placed on fluids and pain medications.The shocking stopped 3 days later, but the patient believed the implant stopped working and either the implantable neurostimulator (ins) or the leads were malfunctioning.It was noted that she had been admitted to the hospital 4 different times with gastroparesis.She had been to the emergency room and hospitalized with her complications multiple times in the last 6 months.She hadn't been feeling well; she was so weak and too sick to get on an airplane.It was noted that she was having a jpouch procedure on (b)(6) 2015.She couldn't have the procedure until she saw someone familiar with her device.She was trying to find a healthcare provider (hcp).

Event Description

The patient later called back regarding already reported issues.The patient needed a doctor in texas.The patient was in a hospital in texas and was working with a surgeon.The patient wanted to know if there were any enterra physicians near her or can get her surgeon a physician programmer to read her ins (implantable neurostimulator ).The patient had been having problems with therapy/ device since (b)(6) 2015.The manufacturer's representative responded with the name of a healthcare provider who had a programmer.

Event Description

Additional information received from the consumer reported that the patient was hurting so bad and had pain and burning right by the implantable neurostimulator (ins) since (b)(6) 2016.The patient's abdomen was hurting so bad and wanted to know if heating pads would affect their device.It was almost like a shocking feeling.The patient experienced a same episode earlier in the year and was hospitalized for a week.The indication for use for this patient was gastric stimulation.

Event Description

Additional information received from the consumer reported the device was shocking her.There was an electrical storm last night and that was when the shocking happened.Along with the shocking, the consumer was experiencing a burning sensation in her abdomen, severe abdominal pain, and ears were popping.This happened once before when she was in another state and an electrical storm had come through.The consumer noted she was put in touch with a doctor, but the doctor no longer works with these devices and needs help finding another doctor.She wanted to make sure that her lead wires were not ¿frying up.¿ the last time the shocking happened, she was able to see her previous doctor who reset the device.Additional information received from the representative provided a doctor for the consumer to connect with.Information received from the consumer reported not being able to find a doctor and stated she was in the hospital.The doctor at the hospital did not work with the device and did not have the equipment to turn stimulation off.The consumer was very upset and needed help turning stimulation off because it was still shocking her.

Manufacturer Narrative

Continuation of d10: product id 435135.Serial# (b)(6).Implanted: (b)(6) 2010.Product type lead product id 435135.Serial# (b)(6).Implanted: (b)(6) 2010.Explanted: product type lead medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.They reported that they had "some serious shocking" with their original implant and stated this was around the time when some implants were recalled.They will call back to provide event date as the patient did not know event date on call.Agent had a very hard time following the patient throughout call and made best attempt to gather all relevant information.Agent did not ask about the circumstances that led to the reported issue.Documented historical information patient provided.

• 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
• MDR Report Key: 4757446
• MDR Text Key: 5784995
• Report Number: 3004209178-2015-08678
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/04/2021

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: 01/28/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 06/02/2021
• Supplement Dates FDA Received: 10/28/2015; 01/07/2016; 08/29/2016; 11/17/2016; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR