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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SINGLE EXTENSION; SCS EXTENSION
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ST. JUDE MEDICAL - NEUROMODULATION SINGLE EXTENSION; SCS EXTENSION Back to Search Results
Model Number 3383
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Pocket Erosion (2013)
Event Date 08/22/2013
Event Type  Injury  
Event Description
Device 2 of 4.Reference mfr report: 1627487-2014-02010, 1627487-2014-02425, 1627487-2014-02426.
 
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
SINGLE EXTENSION
Type of Device
SCS EXTENSION
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
arnie ochoa
6901 preston rd.
plano, TX 75024
9723098090
MDR Report Key3919150
MDR Text Key21808637
Report Number1627487-2014-02424
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 Other
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/01/2013
Device Model Number3383
Device Lot Number3326481
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SCS ANCHOR: MODEL 1192 (X2); IMPLANTED:; SCS LEAD: MODEL 3186 (X2); IMPLANTED:
Patient Outcome(s) Other;
Patient Age66 YR
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