MAUDE Adverse Event Report: MEDTRONIC ENTERRA II NEUROSTIMULATOR

Model Number 37800

Device Problems Defective Component (2292); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Discharge (2225); No Code Available (3191)

Event Date 10/31/2017

Event Type  Injury  

Event Description

Infected enterra site.Device permanently removed.Initial device placed on (b)(6) 2013.The battery was no longer working on (b)(6) 2017 office visit.Device ipg was replaced surgically on (b)(6) 2017.Pt fell shortly after replacement and opened up the incision site.She went to the emergency department and site was sutured closed again.On (b)(6) 2017, pt went to see her primary care provider because she continued to have serous drainage from the incision site.Her primary care asked her to see dr.(b)(6), the surgeon.On (b)(6) 2017, the ipg was removed.Debridement of skin, muscle and fascia for necrotizing infection with removal of mesh.Leads preserved in pt.On (b)(6) 2017, replacement surgery of peripheral neurostimulator pulse generator in a new location.Leads were located and cleaned prior to attaching.Device interrogated and programmed.There was no evidence of infection.On (b)(6) 2017, pt had been doing well since replacement surgery on (b)(6) 2017.She went to her primary doctor and was placed on augmentin for redness and drainage from incision site 1 week prior visit in our office (b)(6) 2017.The site continued to have drainage and now had a small opening in the middle of the wound.On (b)(6) 2017 surgery was done to remove the enterra ipg and leads due to infection.On (b)(6) 2017, culture shows staphylococcus aureus, pt being treated with antibiotics.

• Brand Name: ENTERRA II NEUROSTIMULATOR
• Type of Device: ENTERRA
• Manufacturer (Section D): MEDTRONIC; 7000 central ave, ne; minneapolis MN 55423
• MDR Report Key: 7053836
• MDR Text Key: 92876629
• Report Number: 7053836
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2017

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 Model Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2017
• Distributor Facility Aware Date: 10/30/2017
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 69