• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2019, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a materials manager at a hospital via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of gastric stimulation.It was reported that the patient had pain at the pocket site so the device system was removed.No external issues were noted other than pain at the pocket site.The issue was resolved at the time of the report.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 Key9446479
MDR Text Key180709519
Report Number3004209178-2019-23525
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 company representative,other
Reporter Occupation Other
Type of Report Initial
Report Date 12/10/2019
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? No
Device Operator Health Professional
Device Expiration Date12/28/2017
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/10/2019
Date Device Manufactured07/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
-
-