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

Model Number 37800

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

Patient Problems Dehydration (1807); Hemorrhage/Bleeding (1888); Nausea (1970); Therapeutic Effects, Unexpected (2099); Malaise (2359)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: advisa dr mri surescan pacemaker (1) capsurefixnovus leads (2).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 provider (hcp) reported that a patient had been sick since implant and had no therapy relief.The patient later reported they had nausea, bleeding, and were dehydrated.They needed to have home healthcare and an iv twice a day.They mentioned they were getting their strength back.The patient noted they received a lot of information from the manufacturer after the implant and said would be niceif it had more detail.They did not receive any follow up call from the hcp or the manufacturing representative.The patient wanted to find an hcp that was closer to them in order to address the symptoms.It was noted that the patient had three pacemakers and confirmed all the replacements were due to normal battery depletion.The implantable neurostimulator (ins) indication for use was not clear at the time of the report.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6274785
• MDR Text Key: 65665008
• Report Number: 3004209178-2017-01629
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

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: 03/28/2018
• 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: 12/27/2016
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: 12/27/2016
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 10/06/2016
• 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: 54 YR