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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 Premature Discharge of Battery (1057)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2014
Event Type  Injury  
Event Description
It was reported that the patient's scs ipg will be explanted and replaced due to premature battery depletion.
 
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
EONC
Type of Device
SCS IPG
Manufacturer (Section D)
ST JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
rachel blackwell
6901 preston rd.
plano, TX 75024
9725264637
MDR Report Key3937215
MDR Text Key4601775
Report Number1627487-2014-03444
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 06/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2014
Device Model Number3688
Device Lot Number3591358
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2012
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
IMPLANT DATE:; SCS LEAD: MODEL 3219,
Patient Age75 YR
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