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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL NEUROSTIMULATION DEVICE; NEUROSTIMULATOR
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ST. JUDE MEDICAL NEUROSTIMULATION DEVICE; NEUROSTIMULATOR Back to Search Results
Model Number 3662
Device Problems Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)
Patient Problem No Code Available (3191)
Event Date 06/16/2016
Event Type  Injury  
Event Description
From insertion to my lower back, the controller had constant problems taking to the generator/battery.Additionally, once on the generator/battery is activated, the unit would be very warm and become uncomfortable.Due to the heat issue, i turned off the unit in early (b)(6).Even after the generator/battery were completely off, the unit was still radiating heat.Over the last couple months, i have had severe instances where the area around the generator/battery had small sharp momentary shocks.Several meetings with the st.Jude medical area rep, trying to address the issue of controller and generator/battery communications issues.
 
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Brand Name
NEUROSTIMULATION DEVICE
Type of Device
NEUROSTIMULATOR
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key6063239
MDR Text Key58756487
Report NumberMW5065659
Device Sequence Number1
Product Code GZB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3662
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/26/2016
Type of Device Usage N
Patient Sequence Number1
Treatment
CARBIDOPA 25MG; COUMADIN; DOXEPIN; HYDROXZINE PAMOTE; LAMOTRIGINE ; LEVODOPA 100MG; MULTI VITAMIN ; PRAZOSIN; RANITIDINE; SERTALINE; SIMVASTATIN
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age62 YR
Patient Weight94
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