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

Model Number 37800

Device Problems Unstable (1667); Impedance Problem (2950)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Date of event: no information.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/ pelvic floor.The patient reported pain at the battery site.Upon examination the battery was flipping outward.The doctor also reported the impedance was out of range.The doctor was going to take the patient to surgery and see what might be causing the issue.

• 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: 14013982
• MDR Text Key: 288597541
• Report Number: 3004209178-2022-04263
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2022

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: 02/14/2023
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/05/2022
• Date Device Manufactured: 08/16/2021
• 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): Required Intervention
• Patient Sex: Male