Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC LEAD GASTRIC; IMPLANT
  • 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 LEAD GASTRIC; IMPLANT Back to Search Results
Catalog Number 4351-35
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Nausea (1970)
Event Date 08/02/2017
Event Type  Injury  
Event Description
On (b)(6)2017: a (b)(6) year old female underwent a robotic insertion of a gastric neurostimulator and gastric neurostimulator leads x2 for gastroparesis.On (b)(6)2017: patient was scheduled for an upper gi series due to nausea.Results revealed an incidental linear foreign body overlying the left abdomen measuring 13.5 cm in length.Patient returned to the operating room for removal of gastric pacemaker lead wire.The gastric pacemaker lead was found in the intramuscular portion of the tract through the abdominal wall (left lower quadrant) which could not be seen intraperitoneally or subcutaneously during the previous operation.It was removed easily.The lead measured approximately 13.0 cm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEAD GASTRIC
Type of Device
IMPLANT
Manufacturer (Section D)
MEDTRONIC
minneapolis MN 55432
MDR Report Key6851357
MDR Text Key85604987
Report NumberMW5072025
Device Sequence Number1
Product Code LNQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/26/2019
Device Catalogue Number4351-35
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
-
-