MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Fever (1858); Muscle Weakness (1967); Nausea (1970); Seizures (2063); Vertigo (2134); Blurred Vision (2137); Vomiting (2144); Dizziness (2194); Dysphasia (2195); Viral Infection (2248); Complaint, Ill-Defined (2331); Deformity/ Disfigurement (2360); Impaired Healing (2378); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that a patient had a device change due to normal battery depletion in april and only the implantable neurostimulator (ins) was changed, not the leads.The device was set at default settings.The patient had had a lot of surgeries, this one was supposed to be a ¿piece of cake¿ but it took a long time to recover from it.The patient had fevers and mononucleosis five times in over a year.She had increased nausea and vomiting and the settings were increased to 10 milliamps.Then she had symptoms of slurred speech and numbness.In june she started getting numbness in her face and lips.It felt like novocain never wore off and the whole right side of the neck and tongue were affected.There was also an effect on the fingers on the right hand, the patient lost strength in the right hand, and her coordination was off.It was thought the patient had strokes.The patient also called them epileptic seizures.Since (b)(6) 2014, the patient started getting these episodes every day and had 100 episodes every day.Her face got disfigured, her eyes rolled back into her head, and there were episodes where her eyes closed.The patient¿s balance was off and she also had blurred vision in her right eye, sensitivity at her scalp, vertigo, and dizziness.She had gone to the hospital and had been to five different neurologists.Doctors were thinking that it was non-epileptic seizures.The patient thought it was ¿messed up electrical impulses¿ in the body.Troubleshooting included a local ct scan.No actions were taken to resolve the issue and the event cause was not determined.It was unknown if there was a 50 percent or greater symptom reduction.The patient was not recovered and the issue was ongoing.

Manufacturer Narrative

Concomitant product: product id 435135, serial # (b)(4), implanted: (b)(6) 2003, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2003, product type lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4197342
• MDR Text Key: 4982016
• Report Number: 3004209178-2014-20277
• 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
• Report Date: 09/30/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 10/23/2014
• Date Device Manufactured: 02/20/2014
• 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
• Patient Age: 00046 YR