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

Model Number 37800

Device Problems Unstable (1667); Malposition of Device (2616); Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Tissue Damage (2104); Complaint, Ill-Defined (2331)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had a revision.When their device was implanted, it was not put in correctly.Apparently, there were stitches put in and, after the surgery, the stimulator began to flip out and would stick straight out.The patient would catch their arm on the stimulator if they were sitting down and had their arm against their side.This would push the stimulator down, which was painful and awkward.On (b)(6)2018, the patient had a revision surgery.It was found that the movement of the stimulator had elongated a muscle that it was attached to and, therefore, the patient developed a pocket underneath the stimulator that allowed it to move more freely.The surgeon closed this pocket and ¿tacked¿ the stimulator down so that it was laying flat against the stomach wall.The patient also reported pain underneath the stimulator due to the muscle issue.At the time of the report, the stimulator was working fine and the patient expressed satisfaction with the device/therapy.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer (con).It was reported that the device only had one stitch on the bottom edge.That permitted the stimulator to flip outward, which started a month after they were implanted.

Manufacturer Narrative

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

• 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: 7739618
• MDR Text Key: 115704167
• Report Number: 3004209178-2018-17152
• Device Sequence Number: 0
• Product Code: LNQ
• 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
• Report Date: 10/04/2018

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: 05/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/24/2018; 08/08/2018
• Supplement Dates FDA Received: 09/14/2018; 10/04/2018
• Date Device Manufactured: 12/13/2016
• 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: 67 YR
• Patient Weight: 68