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

Model Number 37800

Device Problems High impedance (1291); Migration or Expulsion of Device (1395)

Patient Problem Internal Organ Perforation (1987)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Date is approximate.Concomitant medical products: product id :4351-35, serial# : (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2022, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6), 2013, explanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 08-may-2015, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 08-may-2015, 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 gastric stimulation and gastrointestinal/ pelvic floor.It was reported that the patient was doing great as far as her symptom relief.Their impedance is out of range (2<(>&<)>3 is 1943) c <(>&<)> 2 is 1313 and c <(>&<)> 3 is 740.They were seen last december and was out of range at that time as well but doing fine with symptoms.The cause/contributing factors were unknown.No actions/interventions had been taken or planned, the issue was unresolved.No patient symptoms were reported.Additional information was received from a manufacturer representative (rep).The rep reported that the patient was getting a battery replacement as well as a possible lead replacement on (b)(6) 2022.It was later reported that the hcp did an endoscopy on the patient due to continued impedance issue.They found that the lead had migrated into the lumen of the stomach.Both leads and the battery were removed and replaced with a new system.

• 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: 13560894
• MDR Text Key: 287134111
• Report Number: 3004209178-2022-02250
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Date Device Manufactured: 07/26/2018
• 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 Outcome(s): Life Threatening
• Patient Age: 30 YR
• Patient Sex: Male