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

Model Number 37800

Device Problems Break (1069); Migration or Expulsion of Device (1395); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that for the gastric stimulator lead removal, after the doctor made an incision through the gastric stimulator pocket, they identified the generator.It had been spinning around the pocket freely and therefore pulled the wires and it appeared as if the wires may have been damaged.There was no way to tell just by looking at them as they were not fully divided.Therefore, the doctor had to replace the gastric stimulator generator as the one they had was fully depleted and could not be interrogated.Therefore the old generator was disconnected from the electrodes.A new generator was connected to electrodes and the doctor checked the impedances of the device.Lead # 2 had impedances greater than 20,000.Lead # 3 had impedances about greater than 3000.Therefore there was no way to establish the stimulator.The doctor called the husband and discussed this with them and the husband agreed with just removing the gastric stimulator system and seeing how the patient does with pyloroplasty with the knowledge that the doctor could go back and place a gastric stimulator laparoscopically as an outpatient in 2 to 3 months if that was necessary.Therefore, the doctor dissected free the leads and stapled and removed them from the stomach.The doctor sent the leads with the gastric resection to the university of louisville for staining of the interstitial cells of the cajal to help evaluate whether or not the patient could respond to future gastric stimulation.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, lot#: unknown, explanted: 2021-06-17, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: unknown, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13694965
• MDR Text Key: 295359515
• Report Number: 3004209178-2022-02988
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Date Device Manufactured: 07/03/2018
• 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 Age: 53 YR
• Patient Sex: Female