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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 0.5
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ST. JUDE MEDICAL - NEUROMODULATION 4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 0.5 Back to Search Results
Model Number 6149
Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/05/2014
Event Type  Injury  
Event Description
Device 3 of 4.Reference mfr report: 1627487-2014-15898, reference mfr report: 1627487-2014-15899, reference mfr report: 1627487-2014-15901.
 
Event Description
Device 3 of 4.Reference mfr report: 1627487-2014-15898, reference mfr report: 1627487-2014-15899, reference mfr report: 1627487-2014-15901.
 
Event Description
Device 3 of 4 reference mfr report: 1627487-2014-15898 reference mfr report: 1627487-2014-15899 reference mfr report: 1627487-2014-15901.
 
Manufacturer Narrative
This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.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.
 
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
4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 0.5
Type of Device
DBS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key4369928
MDR Text Key5164692
Report Number1627487-2014-15900
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/28/2015
Device Model Number6149
Device Lot Number4060536
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received01/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2013
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 Age45 YR
Patient Weight65
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