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

Model Number 37800

Device Problem Improper Device Output (2953)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The healthcare provider (hcp) reported that the patient was admitted to the hospital the day prior to this report for a bowel obstruction.The hcp wanted to turn the implantable neurostimulator (ins) off because the stimulation was adding to the pain the patient was having.This was noted to be sudden, 2-3 days ago.Additional information received from the manufacturer representative (rep) reported that he had a mmb application card.He had tried multiple times in different positions but couldn't turn stimulation off using the emergency button.He was going to check the application card in the other clinician programmer (cp) that he had.Relevant medical history included gastric stimulation and gastrointestinal/pelvic floor.Follow-up was performed to determine what actions were taken to address the event, if a cause had been determined, and if it was resolved.

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

Additional information received from the health care provider (hcp) reported that the patient's symptoms resolved and there was no evidence of obstruction.Bowel obstruction was not present.There were no complications related to the implantable neurostimulator (ins).

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5474905
• MDR Text Key: 39527244
• Report Number: 3004209178-2016-03799
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Date Device Manufactured: 06/30/2015
• 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