• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number 37800
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 07/01/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for the treatment of gastric stimulation.It was reported that the patient was playing with their grandson and they got hit on their ins and had been in terrible pain since.They had gone a week to a week and a half without eating.The consumer mentioned the patient had been to the er and no one could do anything with the ins.The consumer requested to see a manufacturer representative (rep) so they were redirected to a healthcare professional (hcp).No further patient complications were reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8817261
MDR Text Key151909370
Report Number3004209178-2019-14055
Device Sequence Number1
Product Code LNQ
UDI-Device Identifier00643169614246
UDI-Public00643169614246
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H990014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 07/23/2019
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 Date03/14/2018
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/22/2019
Initial Date FDA Received07/23/2019
Date Device Manufactured09/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age50 YR
-
-