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

Model Number 37800

Device Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Electric Shock (2554)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 435135 lot# serial# (b)(4) implanted: (b)(6) 2009 explanted: product type lead product id 435135 lot# serial# (b)(4) implanted: (b)(6) 2009 explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 16-sep-2011, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 16-sep-2011, udi#: (b)(4)if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that  that the patient was admitted to the hospital for nausea and vomiting up blood.They took a ct scan and the lead was broken.The patient had been getting little shocks like putting their tongue on a battery and it was getting worse.They were going up through the chest and through their back and down to their legs.The patient stated it hurt like hell.They gave the patient liquid pain medications, but their stomach would not be able to break it down due to their condition.  the circumstances that led to the reported events were unknown.They were redirected to their healthcare provider to further discuss the issue.Reviewed their hcp can contact a manufacturer representative to turn the device off if need be.A courtesy email was sent to the field. .

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12287823
• MDR Text Key: 265387677
• Report Number: 3004209178-2021-12018
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• 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
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2021
• Date Device Manufactured: 05/14/2021
• 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
• Patient Age: 35 YR