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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG Back to Search Results
Model Number 3789
Device Problem Unintended Movement (3026)
Patient Problems Edema (1820); Pain (1994); Post Operative Wound Infection (2446)
Event Date 02/11/2015
Event Type  Injury  
Event Description
Follow up information identified the cultures came back negative.The patient reports her pain is better.
 
Event Description
Follow up information identified the patient continued to experience pain at the ipg site with a shocking sensation because the ipg was flipping in the pocket.The patient underwent surgical intervention to remove and replace her ipg which resolved the issues,.
 
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.
 
Manufacturer Narrative
Evaluation codes: results: the complaint could not be confirmed for pain at ipg site-.As received, the returned ipg revealed no visual anomaly.The ipg passed all functional testing on the autotester.Neither anomalous outputs nor erroneous signals were observed from the non-programmed channels or the can.The analysis resulted in normal device characteristics.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
It was reported the patient is experiencing pain at her ipg site.The patient reports the ipg is flipping in the pocket and she is experiencing severe pain from the ipg site to the lead site.The patient also reports she is experiencing warmth when the scs system is in use.In addition, the site is painful and puffy.Follow up information identified x-rays were taken and showed no anomalies.The physician obtained fluid from the ipg pocket site and the patient was prescribed antibiotics.
 
Manufacturer Narrative
(b)(4).Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records." 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
PROTEGE IPG, 16-CHANNEL RECHARGEABLE
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key4576215
MDR Text Key5641881
Report Number1627487-2015-26104
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,Followup,Followup,Followup
Report Date 07/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2016
Device Model Number3789
Device Lot Number4728269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received07/01/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2014
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
MODEL 3228, SCS LEAD
Patient Outcome(s) Other;
Patient Age68 YR
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