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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG Back to Search Results
Model Number 3789
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pocket Erosion (2013); Discomfort (2330)
Event Type  Injury  
Event Description
Follow-up information revealed the patient is happy with her new ipg placement and paresthesia coverage and the issue is now resolved.
 
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
It was reported the patient experienced discomfort at the ipg site.It was also reported the patient's ipg appeared to be superficial and protruding out of the skin.Subsequently, the patient underwent surgical intervention on (b)(6) 2015, where the ipg was explanted and replaced with a different model and relocated.
 
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.
 
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
Corrected data: date of explant is (b)(6) 2015, not (b)(6) 2015 as previously reported.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
Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015.
 
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Brand Name
PROTEGE IPG, 16-CHANNEL RECHARGEABLE
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key4621748
MDR Text Key5726224
Report Number1627487-2015-23164
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,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/28/2016
Device Model Number3789
Device Lot Number4887571
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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