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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI IPG SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI IPG SCS IPG Back to Search Results
Model Number 3771
Device Problem Device Stops Intermittently (1599)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative

The manufacturer 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. The manufacturer defers to the patient's physician regarding medical history.

 
Event Description

It was reported the patient¿s ipg would turn off intermittently. Troubleshooting did not alleviate the issue, therefore the physician explanted and replaced the ipg to resolve the issue. Postoperatively, effective stimulation was reported.

 
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Brand NamePROTÉGÉ MRI IPG
Type of DeviceSCS 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 (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
joanne story
6901 preston road
plano, TX 75024
9725264875
MDR Report Key7531605
MDR Text Key108848764
Report Number3006705815-2018-01215
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2017
Device MODEL Number3771
Device Catalogue Number3771
Device LOT Number5228859
OTHER Device ID Number05415067017086
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/14/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/22/2018 Patient Sequence Number: 1
Treatment
MODEL 1192, SCS ANCHOR; MODEL 1194, SCS ANCHOR; MODEL 3228, SCS LEAD
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