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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16
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ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 Back to Search Results
Model Number 3219
Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)
Patient Problems Therapeutic Effects, Unexpected (2099); Shock from Patient Lead(s) (3162)
Event Date 12/20/2013
Event Type  Injury  
Event Description
Device #2 of 2.Reference mfr.Report: 1627487-2014-26032.
 
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
LAMITRODE TRIPOLE 16
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
tanja hoffman
6901 preston rd.
plano, TX 75024
9723098520
MDR Report Key3682868
MDR Text Key4259881
Report Number1627487-2014-26039
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 12/20/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/01/2015
Device Model Number3219
Device Lot Number3904350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/20/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age45 YR
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