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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION DUAL EXTENSION; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION DUAL EXTENSION; SCS LEAD Back to Search Results
Model Number 3346
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problem Inadequate Pain Relief (2388)
Event Date 01/29/2015
Event Type  Injury  
Event Description
Device 4 of 4.Reference mfr report # 1627487-2015-00001, 1627487-2015-00002 and 1627487-2015-00003.
 
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
DUAL EXTENSION
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX 75024
Manufacturer Contact
courtney weddington
6901 preston rd.
plano, TX 75024
9725264859
MDR Report Key4493867
MDR Text Key15239603
Report Number1627487-2015-00018
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 01/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2013
Device Model Number3346
Device Lot Number3365422
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/29/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2011
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 Age52 YR
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