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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 3186
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vomiting (2144)
Event Date 02/25/2014
Event Type  Injury  
Event Description
It was reported the pt vomited during her permanent procedure.As a result, the physician abandoned the procedure.Two leads (with the same lot number) were opened but never used.
 
Manufacturer Narrative
Sjm has limited info 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
OCTRODE
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
benjyna obasuyi
6901 preston rd.
plano, TX 75024
9725264659
MDR Report Key3692800
MDR Text Key4254494
Report Number1627487-2014-25201
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 02/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2015
Device Model Number3186
Device Lot Number4363857
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/10/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/25/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2013
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 Age67 YR
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