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

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Vomiting (2144); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 healthcare professional (hcp) reported a consumer was in the icu as they have a tracheotomy, had multiple strokes, and most recently locked-in syndrome from a stroke.Because of the locked-in syndrome, the consumer could not talk or communicate.The hcp stated the consumer was transferred to them from rehab ¿a solid week ago¿ with gi bleeding and vomiting (rehab facility described it as hematemesis).The hcp believed the consumer was admitted to their facility on (b)(6) 2016.Prior to this, the consumer was in jail so it was unknown if they had any follow-up care for the device.The hcp stated the consumer had not had any bleeding episodes, but once a day, possibly more frequent than that, the consumer projectile vomits.When the consumer was admitted, they planned to do an egd, but could not as the consumer never had a drop in h and h and they were having these episodes, but noted the consumer was guaiac negative.The stroke/locked-in syndrome occurred (b)(6) 2016, and the gi issues occurred (b)(6) 2016.A representative was requested to check the device.

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: 6288626
• MDR Text Key: 66113602
• Report Number: 3004209178-2017-02100
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2008
• 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: 01/03/2017
• Initial Date FDA Received: 01/30/2017
• Supplement Dates Manufacturer Received: 01/03/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 01/12/2007
• 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): Hospitalization
• Patient Age: 38 YR