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 PENTA; SCS LEAD
  • 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 PENTA; SCS LEAD Back to Search Results
Model Number 3228
Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Patient Problems Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
Event Date 06/12/2014
Event Type  Injury  
Event Description
It was reported the patient was experiencing a pulling sensation at her scs lead site and had two wires protruding from her back that fell out after a shower.The patient stated she turned off her stimulation out of concern her system might not be functioning normally.Patient was advised to consult her physician to determine next steps to address the issue.
 
Manufacturer Narrative
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
PENTA
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL -NEUROMODULATION
plano TX
Manufacturer Contact
logan farmer
6901 preston rd.
plano, TX 75024
9725269611
MDR Report Key3949659
MDR Text Key16446516
Report Number1627487-2014-08093
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Type of Report Initial
Report Date 06/12/2014
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 Expiration Date11/01/2013
Device Model Number3228
Device Lot Number3538809
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/12/2014
Initial Date FDA Received07/01/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2011
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
SCS IPG, MODEL: 3788; IMPLANT DATE:
Patient Outcome(s) Other;
Patient Age62 YR
-
-