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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON RECHARGEABLE IPG, 16-CHANNEL; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION EON RECHARGEABLE IPG, 16-CHANNEL; SCS IPG Back to Search Results
Model Number 3716
Device Problem Use of Device Problem (1670)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/16/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient was no longer receiving stimulation after not charging for at least 2 months.It was also reported the patient was unable to establish communication between her scs ipg and external devices.An sjm representative confirmed the issue using external devices.As a result, the scs ipg was explanted and replaced.
 
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Brand Name
EON RECHARGEABLE IPG, 16-CHANNEL
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key5524631
MDR Text Key41119318
Report Number1627487-2016-01423
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 Other
Type of Report Initial
Report Date 03/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2008
Device Model Number3716
Device Lot Number49956
Was Device Available for Evaluation? No
Date Manufacturer Received03/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2006
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 Outcome(s) Other;
Patient Age66 YR
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