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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EONC; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION EONC; SCS IPG Back to Search Results
Model Number 3688
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Discomfort (2330)
Event Date 03/14/2014
Event Type  Injury  
Event Description
It was reported the pt experienced discomfort due to the ipg size.Reportedly, there were no defects with the original device.Follow-up identified surgical intervention was undertaken on (b)(6) 2014 and the existing ipg replaced with a smaller device.Effective therapy was achieved postoperatively.The issue has resolved.
 
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
EONC
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
melissa nkematu
6901 preston rd.
plano, TX 75024
9723092520
MDR Report Key3764956
MDR Text Key4488140
Report Number1627487-2014-01210
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,company representative
Reporter Occupation Not Applicable
Type of Report Initial,Followup
Report Date 06/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/01/2015
Device Model Number3688
Device Lot Number4126220
Was Device Available for Evaluation? No
Date Manufacturer Received06/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
IMPLANTED:
Patient Outcome(s) Other;
Patient Age53 YR
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