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: ST. JUDE MEDICAL - NEUROMODULATION BRIO; DBS IPG
  • 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
 

ST. JUDE MEDICAL - NEUROMODULATION BRIO; DBS IPG Back to Search Results
Model Number 3788
Device Problem Fluid/Blood Leak (1250)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/01/2013
Event Type  Injury  
Event Description
It was reported the patient (b)(6) has experienced diminished therapy relief from his dbs system.There is concern of possible fluid intrusion into the ipg header.Surgical intervention will be undertaken at a later date to address this issue.
 
Manufacturer Narrative
This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BRIO
Type of Device
DBS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
courtney weddington
6901 preston rd.
plano, TX 75024
9725264859
MDR Report Key3850417
MDR Text Key19486482
Report Number1627487-2014-00319
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2011
Device Model Number3788
Device Lot Number2810983
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
IMPLANT DATE:; DBS EXTENSION: MODELL 6345 (2); IMPLANT DATE:; DBS LEAD: MODE 6145 (2)
Patient Outcome(s) Other;
-
-