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

Model Number 37800

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 12/12/2017

Event Type  Injury  

Event Description

A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that a patient had the implantable neurostimulator (ins) system implanted in (b)(6) 2017 and the patient was having severe symptoms again and needed to have a repair, possible lead and battery exchange, possible replacement and removal.They had the patient scheduled for (b)(6) 2018.The hcp wanted the device interrogated prior to the device so they knew what they were encountering.After an abdominal series was performed it was noted that the leads look intact but it seemed that the device keeps flipping upward when they lay down.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 healthcare professional (hcp).It was reported that the patient was very thin, which was likely the issue and the device flipping was due to the patient changing positions.The pocket was revised and the adhesions were cleared.It was noted that the device was unaffected so it did not need to be replaced.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 manufacturer representative.It was reported that the pocket revision took place on 1/3/18 and was successful.No further complications were reported/anticipated.

• 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: 7140586
• MDR Text Key: 95583004
• Report Number: 3004209178-2017-26131
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2018

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: 01/14/2019
• 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: 12/12/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/03/2018; 02/01/2018
• Supplement Dates FDA Received: 01/25/2018; 02/23/2018
• Date Device Manufactured: 07/18/2017
• 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 Age: 64 YR