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

Model Number 3116

Device Problems Premature Discharge of Battery (1057); Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems Dehydration (1807); Purulent Discharge (1812); Fever (1858); Low Blood Pressure/ Hypotension (1914); Pain (1994); Sepsis (2067); Swelling (2091); Tachycardia (2095); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead e.The initial reporter was an unknown receptionist from the doctor's office.

Event Description

The healthcare provider (hcp) reported via a manufacturer representative (rep) that the patient had her implantable neurostimulator (ins) removed during exploratory surgery due to "infected material in pouch." the patient stated that she was doing ok for two and a half years after implant.She still could not work, but kept food down more.She could only eat when she had the machine.Then the infection began and was observed on (b)(6) 2016.A ct scan was taken that same day and the strain was unknown.She mentioned that the infection almost killed her and was present at the ins and lead.One day she was fine and the next day she was screaming in pain.According to her, the emergency medical technician (emt) suspected she was septic.Her blood pressure was bottoming out constantly and her heart rate was extremely high.She was throwing up and her entire abdomen was swollen front to back and looked like she was six months pregnant.She had a fever of almost 102 degrees and was dehydrated.She was brought to the hospital on the (b)(6).The leads were intact and when the hcp tried to check the ins he told her the ins battery was dead.The battery died only two years after implant.The patient stated that the hcp told her the ins would last five years, but it only lasted one and a half years, and the infection was from the ins, not from the surgery.She was put on intravenous (iv) antibiotics and iv pain medication and was kept at the hospital for two weeks before the hcp did the surgery to remove the ins.The hcp was going to replace the ins, but when he opened her up there was a ton of pus and infection, so he had to remove the ins and was not able to implant another one.The ins was the only device removed and the leads remained implanted as she would be getting a new ins once the infection clears.However, the patient reported that she still had half a lead attached to the stomach wall and the other half of the lead was removed.She was put on oral antibiotics.The cause of the infection was not determined and it cleared.She was scheduled for another implant on (b)(6) 2016, but it was cancelled and moved to (b)(6) 2016.The patient's indication(s) for use were bowel dysfunction and sacral nerve stimulation.

Manufacturer Narrative

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.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6015295
• MDR Text Key: 56917128
• Report Number: 3004209178-2016-21440
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2016
• Date Device Manufactured: 10/17/2014
• 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; Life Threatening; Required Intervention
• Patient Age: 31 YR