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

Model Number 37800

Device Problems Degraded (1153); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Swelling (2091); Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); Malaise (2359); No Code Available (3191)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and 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.Patient code (b)(4) is applicable to the leads (b)(4).Evaluation code-conculsion is applicable to the leads (b)(4).Evaluation code-conclusion is applicable to the ins (b)(4).

Event Description

A patient reported they had been doing good for a few months, after they put the implantable neurostimulator (ins) in, but for the last month, the patient had been really, really sick.Since the patient was sick, they went to the emergency room (er), and to the stomach doctor, where they did an endoscopy.The patient stated that based on the pictures they took on (b)(6) 2017, the patient 's body was rejecting the ins and one of the leads was infected inside of the their stomach.They stated something was seriously wrong.The healthcare provider (hcp) wanted to take the current ins out and replace it with a new one.They wanted a manufacturing representative to be present at the surgery, but they were having difficulty getting in touch with one.The surgery was scheduled for (b)(6) 2017.The patient further mentioned they had nothing but frustrations since getting the implant, because they had difficulty finding a managing physician when they moved.They stated they did not know why they were not on antibiotics to help, in the meantime.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 consumer.It was reported that the replacement of the system resolved the reported issues.It was noted that the cause of the eroded leads was not determined.No further complications were reported/anticipated.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id (b)(4) lot# serial# (b)(4) implanted: (b)(6) 2015 explanted: (b)(6)2018 product type lead product id (b)(4) lot# serial# (b)(4) implanted: (b)(4) 2015 explanted: (b)(6) 2018 product type lead: device codes: (b)(4) pertain to product id (b)(4) serial# (b)(4) product type lead and product id (b)(4) serial# (b)(4) product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.It was reported that there was nothing wrong with the patient¿s device and because of the high settings on the patient¿s battery, the battery would need to be replaced.It was noted the setting was higher because that was what was required for the patient¿s symptoms therapy.Additional information was received from a consumer.It was reported that the battery was still fine but the patient did have high settings and that the patient had high settings because the device malfunctioned due to corrosion of one lead.It had been turned up so much because it was not doing what it was supposed to do.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: lead.(b)(4) pertain to: product id: 37800, serial# (b)(4), product type: implantable neurostimulator.(b)(4) pertain to product id: 4351-35, serial# (b)(4), product type: lead and product id: 4351-35, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the patient just had surgery so it was too soon to tell if the replacement resolved the issue with the leads being infected and their body rejecting the ins; the patient was swelled up and in pain.Additional information was received on 2018-feb-02.The patient had to have the system taken out and replaced and that something malfunctioned in the stomach.It was noted that one of the leads eroded in the stomach.The device was working and then the patient started to get really sick, had blood in their stool, their stomach was bleeding inside, and they guessed it was from the lead, but were not sure.The gi doctor did an endoscopy and the patient went to the surgeon and they said the lead was eroding where it was connected to the stomach.It was noted that the lead was taken out and moved to a new area and also that the device and lead was replaced.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: 7186766
• MDR Text Key: 97133331
• Report Number: 3004209178-2018-00733
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2018
• Date Device Manufactured: 12/23/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 93