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

Model Number 3116

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Urinary Tract Infection (2120)

Event Date 09/01/2017

Event Type  Injury  

Event Description

A patient with an implantable neurostimulator (ins), indicated for gastrointestinal/pelvic floor, reported their ins quite working in (b)(6) 2017 and they did not have a doctor.They had a urinary tract infection and it ended up being a group b strep and not an infection.The patient requested a patient manual.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the patient¿s ins had completely stopped.The patient had notified a physician of their ins not working, but they did not know if the hcp would take the patient on.It was noted that no one was doing anything about their group b strep because it was hard to cure, and the issue with the ins not working and group b strep had not been resolved.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the later part of last year, summer 2017, the patient¿s battery depleted, the patient had been without the device, and the hcp said the receptors were not working.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer (con).It was reported that they were planning a surgery for the ins on (b)(6) 2018.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7160608
• MDR Text Key: 96318256
• Report Number: 3004209178-2018-00138
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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,Followup,Followup,Followup
• Report Date: 05/02/2018

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: 11/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/12/2018; 02/28/2018; 04/16/2018
• Supplement Dates FDA Received: 01/24/2018; 03/19/2018; 05/02/2018
• Date Device Manufactured: 05/22/2014
• 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): Other; Required Intervention
• Patient Age: 57 YR