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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL -NEUROMODULATION OCTRODE; SCS LEAD
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ST. JUDE MEDICAL -NEUROMODULATION OCTRODE; SCS LEAD Back to Search Results
Model Number 3183
Device Problems Pocket Stimulation (1463); Low impedance (2285); Impedance Problem (2950)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 06/05/2014
Event Type  Injury  
Event Description
Device 3 of 3 reference mfr report: 1627487-2014-15490.Reference mfr report: 1627487-2014-15491.
 
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.
 
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Brand Name
OCTRODE
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL -NEUROMODULATION
plano TX
Manufacturer Contact
toi milner
6901 preston rd.
plano, TX 75024
9723098107
MDR Report Key3949254
MDR Text Key18366352
Report Number1627487-2014-15492
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 Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2015
Device Model Number3183
Device Lot Number3932283
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/05/2014
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
Treatment
SCS ANCHOR, MODEL 1192 (2); IMPLANT DATE:
Patient Age51 YR
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