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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE; SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE; SCS LEAD Back to Search Results
Model Number 3146
Device Problems Device Operates Differently Than Expected (2913); Battery Problem: High Impedance (2947); Impedance Problem (2950)
Patient Problem Inadequate Pain Relief (2388)
Event Date 05/06/2014
Event Type  Injury  
Event Description
It was reported the pt is w/o stimulation and the amplitude auto-reduces at a certain level.F/u identified 3 invalid contacts with high impedance for the lead in the epidural space.Reprogramming provided some stimulation, however the pt no longer feels it.Surgical intervention may be undertaken as the next course of action.
 
Manufacturer Narrative
Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.
 
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Brand Name
QUATTRODE
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
melissa nkematu
6901 preston rd.
plano, TX 75024
9723092520
MDR Report Key3890483
MDR Text Key4647990
Report Number1627487-2014-01386
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2015
Device Model Number3146
Device Lot Number4097073
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
IMPLANT DATE:; SCS IPG: MODEL 3788; SCS EXTENSION: MODEL 3341(2); SCS LEAD: MODEL 3163 (2); SCS LEAD: MODEL 3166; IMPLANT DATE:; IMPLANT DATE:; IMPLANT DATE:; IMPLANT DATE:; SCS ANCHOR: MODEL 1192
Patient Outcome(s) Other;
Patient Age35 YR
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