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: ABBOTT MEDICAL AXIUM IMPLANTABLE NEUROSTIMULATOR KIT, I; DRG INS
  • 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
 

ABBOTT MEDICAL AXIUM IMPLANTABLE NEUROSTIMULATOR KIT, I; DRG INS Back to Search Results
Model Number MN10200
Device Problem Wireless Communication Problem (3283)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The patient's weight was unable to be obtained.The results/ method and conclusion codes along with the investigation results will be provided in the final report.
 
Event Description
It was reported the patient's drg ins had difficulties consistently communicating with their programmer device.In turn, the patient's drg ins was explanted and replaced (with an scs ipg) to provide resolution.
 
Manufacturer Narrative
The results of the investigation are inconclusive, since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AXIUM IMPLANTABLE NEUROSTIMULATOR KIT, I
Type of Device
DRG INS
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11118652
MDR Text Key225140274
Report Number1627487-2021-00113
Device Sequence Number1
Product Code PMP
UDI-Device Identifier05415067025500
UDI-Public05415067025500
Combination Product (y/n)N
PMA/PMN Number
P150004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/19/2019
Device Model NumberMN10200
Device Catalogue NumberMN10200
Device Lot NumberDB7885
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
-
-