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

Model Number 37800

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Seroma (2069); Blood Loss (2597); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2017, explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

A manufacturing representative (rep reported on behalf of a healthcare provider (hcp) that a patient had a seroma at the pocket site that might have been infected.The patient was scheduled for a possible removal on (b)(6) 2017.The surgeon described it as a possible sinus tract to the pocket.No further complications were reported/anticipated.

Manufacturer Narrative

Evaluation code-conclusion is no longer applicable to the event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the healthcare provider (hcp) noted in the operation notes that there was an infected gastric stimulator.A laparoscopic removal of the gastric stimulator and electrodes was performed on (b)(6) 2017.There was an estimated 20ml of blood loss during the removal.The patient had decompressed a large amount of fluid through their wound.The pocket was full of pus.There was no intra-abdominal infection noted, but there was significant inflammation around the leads at the site of the implant on the stomach.The stomach and visualized peritoneal surfaces and organs otherwise appeared normal.A standard surgical procedure was performed to remove the device and there were no additional issues noted.The patient was sent to recovery in good condition.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the seroma was spontaneously draining at presentation; the drainage was likely pus with residual fluid leaking through the sinus tract.No further complications were reported/anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7044074
• MDR Text Key: 92460327
• Report Number: 3004209178-2017-24025
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2018

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: 12/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 11/18/2017
• Supplement Dates Manufacturer Received: 12/04/2017; 01/22/2018
• Supplement Dates FDA Received: 12/15/2017; 02/07/2018
• Date Device Manufactured: 07/06/2017
• 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): Required Intervention
• Patient Weight: 63