MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Unintended Collision (1429)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Constipation (3274)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8637-40, serial# (b)(4), implanted: (b)(6) 2010, product type: pump.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported they had their gastric device regularly serviced and checked but they were now feeling severe pain.The also mentioned they had a fall in the shower and felt pain under their left rib.The fall was around the same time they started noticing the pain.They went to the emergency room for the pain and an x-ray showed they were "backed up".They were given a medication and stated that it made their bottom bleed.The x-ray was not done to check on a suspected device issue.No further complications are anticipated.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6437786
• MDR Text Key: 70976728
• Report Number: 3004209178-2017-06452
• Device Sequence Number: 1
• 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
• Report Date: 03/27/2017

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: 08/14/2010
• 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: 03/02/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: 03/02/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 02/24/2009
• 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 Age: 47 YR