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

Model Number 3116

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

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Fatigue (1849); Fever (1858); Flatus (1865); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Tachycardia (2095); Vomiting (2144); Dizziness (2194); Hematuria (2558); Abdominal Distention (2601); Weight Changes (2607); Constipation (3274)

Event Type  Injury  

Event Description

It was reported the patient had a fever and was tachycardic about a week after being implanted.It was noted the patient tolerated the procedure well and there were no immediate complications.Cultures were sent and the patient was started on vancomycin and zosyn.The cultures came back positive for fungemia and coagulase negative staphylococci ¿ line infection.Micafungin was recommended in addition to the medication being taken.Since the surgery, the patient had only minimal improvement in nausea and vomiting.The patient did experience vomiting right after meals, which was a new symptom for the patient.Repeated cultures came back negative and the patient was discharged in stable condition.About a month after implant, the patient had experienced many symptoms.These included, weight loss, abdominal pain, bloating/gas, and fatigue.The pain level was 2-3 intermittently and worse with coughing and movement.Tramadol helped the pain.The patient also had some right sided back pain.It was noted the patient had some vomiting, with bread mostly.Minimal constipation was noted in addition to more frequent bowel movements since surgery.There was occasional blood from the incision as well.It was noted the patient did not take their blood pressure medication as well.Later in (b)(6) 2011, it was noted that patient¿s incisions were healing well and were clean, dry, and intact.No erythema was reported.The patient again had abdominal pain when lying on the right side.Additional symptoms included poor appetite, headaches, dizziness, and blood in the urine.The nausea and vomiting was occurring three days a week.The patient was seen for the multiple adjustments from october 2011 to january 2012.Since the initial adjustment, the patient experienced a decrease in nausea and vomiting.The patient experienced nausea two times a week in (b)(6) 2011.In (b)(6) 2012, the patient was complaining of shocking pain on the left side.The patient continued to have occasional headaches and constipation.It was noted the patient was doing overall ¿ok¿ and was to have a follow up in three months.A few months later in september, the patient was complaining of frequent nausea and vomiting.It was noted the patient was admitted to the hospital.Many of the symptoms the patient initially had continued over the timeframe of the event.The device was eventually explanted.Refer to manufacturer report # 3004209178-2014-04199 for information regarding the circumstances around that event.

Manufacturer Narrative

Concomitant medical products: 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.(b)(4).

• 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: 3767768
• MDR Text Key: 20328124
• Report Number: 3004209178-2014-07737
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2014
• Date Device Manufactured: 01/19/2011
• 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): Hospitalization; Required Intervention