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

Model Number 37800

Device Problems Disconnection (1171); Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 18-jul-2021, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 13-feb-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient was experiencing additional pain in their stomach.The doctor did an endoscopy of the stomach on 11/17 and identified the leads had migrated through out the stomach wall into the inside of the stomach.There were no known contributing factors.A divinci robot was used to laparoscopically remove the leads from the outside of the stomach and then endoscopically remove the leads from he inside of the stomach.It was noted the leads were no longer attached, the trumpet anchors and coils were also extracted from the inside of the stomach.It was noted the ins had also been removed.The issue was reported to be resolved at the time of report.Patient status was listed as 'alive-no injury'.It was also noted the manufacturer representative requested device return, but device return was refused.

• 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: 12851779
• MDR Text Key: 281081834
• Report Number: 3004209178-2021-17393
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Date Device Manufactured: 04/03/2019
• 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
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 68 KG