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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Material Deformation (2976); Positioning Problem (3009)

Patient Problems Chest Pain (1776); Nausea (1970); Pain (1994); Vomiting (2144); Malaise (2359)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient thought their machine was out of its pocket because they could feel it moving around in their stomach.They had x-rays to verify this, but they hadn¿t gotten the results yet.About two weeks prior to the report, they had their settings adjusted at the healthcare professional (hcp) office and they hadn¿t been the same since then.They were having nausea and had been vomiting.The patient went to the emergency room (er) and had stress tests done because they were having chest pains.The hcp there told them that the stimulation was causing the muscles around their heart to be painful.No further complications were reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer (con).It was reported that the patient had surgery on (b)(6) 2018.They noted the nausea and vomiting were the way that they stayed.

Manufacturer Narrative

Product id 4351-35 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: product type lead product id 4351-35 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Further information provided by the patient indicated that the device was broken in their stomach.No further complications were reported or anticipated.

Manufacturer Narrative

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.

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer (con).It was reported that the patient had an adjustment and an x-ray because they hadn't felt good at all.The patient was told they would need surgery and stated that it was floating freely and the wires were all tangled up.

• 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: 7698013
• MDR Text Key: 114680691
• Report Number: 3004209178-2018-16021
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 07/25/2018; 07/25/2018; 09/10/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/26/2018; 07/30/2018; 09/19/2018; 10/04/2018; 10/05/2018
• Date Device Manufactured: 11/10/2016
• 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 Age: 50 YR
• Patient Weight: 93