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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 Fluid/Blood Leak (1250)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 1 of 2: reference mfr report#: 1627487-2015-23558.It was reported the patient ((b)(6)) experienced ineffective stimulation.Diagnostic testing revealed impedances were within normal range.Follow-up information revealed the patient's bodily fluid had leaked into the ipg header.Subsequently, the patient underwent surgical intervention on (b)(6) 2015, where the ipg was explanted and replaced with a different model.During the procedure, the patient's lead was cleaned and connected to the new ipg.Reportedly, the patient has effective stimulation coverage postoperative.
 
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 1 of 2.Reference mfr report#: 1627487-2015-23558.Follow-up information revealed the patient's ipg implant date was (b)(6) 2007.
 
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 1 of 2.Reference mfr report#: 1627487-2015-23558.
 
Manufacturer Narrative
Explant date is (b)(6) 2015, not (b)(6) 2015 as previously reported.
 
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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 road
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston road
plano TX 75024
MDR Report Key5092283
MDR Text Key26348373
Report Number1627487-2015-23557
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Followup,Followup,Followup
Report Date 12/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2008
Device Model Number3716
Device Lot Number64720
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2006
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 Age55 YR
Patient Weight90
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