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 NEUROMODULATION UNKNOWN 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 NEUROMODULATION UNKNOWN ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number NEU_ENTERRA_INS
Device Problem Impedance Problem (2950)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that they had issues with a patients presenting with impedances out of range 1-2 months following implant.No outcome was reported regarding this event.A further follow-up is being conducted to obtain this information.A follow-up report will be sent if additional information becomes available.
 
Manufacturer Narrative
Concomitant product: product id neu_unknown_lead, serial # unknown, product type lead.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN ENTERRA
Type of Device
INTESTINAL STIMULATOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 120
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 Key4842089
MDR Text Key16081166
Report Number3007566237-2015-01644
Device Sequence Number1
Product Code LNQ
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 Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNEU_ENTERRA_INS
Device Catalogue NumberNEU_ENTERRA_INS
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/19/2015
Initial Date FDA Received06/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-