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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
Medical Device Problem Code Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 08/15/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The directions for use states that the implant must be charged every 30 days to avoid battery depletion.Based on the information received, the cause of the reported incident is related to user error.
 
Event or Problem Description
It was reported the patient did not recharge the ipg as recommended.As such, the ipg became inoperable.In turn, the patient underwent surgical intervention wherein the device was explanted and replaced.
 
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Brand Name
PROTEGE IPG, 16-CHANNEL RECHARGEABLE
Common Device Name
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key9331061
Report Number1627487-2019-12855
Device Sequence Number419547
Product Code LGW
UDI-Device Identifier05415067027627
UDI-Public05415067027627
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date07/28/2016
Device Model Number3789
Device Lot Number4686912
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/06/2019
Initial Report FDA Received Date11/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Weight64
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