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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ¿ NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 30CM; SCS EXTENSION
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ST. JUDE MEDICAL ¿ NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 30CM; SCS EXTENSION Back to Search Results
Model Number 3343
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 08/19/2014
Event Type  Injury  
Event Description
Device 5 of 9.Reference mr.Report # 1627487-2014-20359, reference mr.Report # 1627487-2014-20358, reference mr.Report # 1627487-2014-20360, reference mr.Report # 1627487-2014-20362, reference mr.Report # 1627487-2014-20364, reference mr.Report # 1627487-2014-20365, reference mr.Report # 1627487-2014-20366, reference mr.Report # 1627487-2014-20367.
 
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.
 
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.
 
Event Description
Device 5 of 9.Reference mfr.Report: 1627487-2014-20358, reference mfr.Report: 1627487-2014-20359, reference mfr.Report: 1627487-2014-20360, reference mfr.Report: 1627487-2014-20362, reference mfr.Report: 1627487-2014-20364, reference mfr.Report: 1627487-2014-20365, reference mfr.Report: 1627487-2014-20366, reference mfr.Report: 1627487-2014-20367.
 
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Brand Name
EXTENSION, DUAL 4 CHANNEL 30CM
Type of Device
SCS EXTENSION
Manufacturer (Section D)
ST. JUDE MEDICAL ¿ NEUROMODULATION
plano TX
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
taruna sharma
6901 preston rd.
plano, TX 75024
9725269635
MDR Report Key4203346
MDR Text Key4981607
Report Number1627487-2014-20363
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,consumer
Type of Report Initial,Followup
Report Date 10/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2008
Device Model Number3343
Device Lot Number64156
Was Device Available for Evaluation? No
Date Manufacturer Received10/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2006
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 Age66 YR
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