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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 Use of Device Problem (1670)
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 stopped recharging their ipg as recommended. In turn, the patient's ipg became inoperable over time. Troubleshooting was unable to resolve the issue. As a result, the patient underwent surgical intervention on (b)(6) 2017 to have their ipg replaced. Effective therapy was restored postoperatively.

 
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Brand NamePROTEGE IPG, 16-CHANNEL RECHARGEABLE
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
taiwo babajide
6901 preston road
plano, TX 75024
9723098568
MDR Report Key7155350
MDR Text Key96066223
Report Number3006705815-2017-07417
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
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 Number4730309
OTHER Device ID Number05415067020192
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/06/2014
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: 12/29/2017 Patient Sequence Number: 1
Treatment
MODEL: 1192, SCS ANCHOR (2); MODEL: 3186, SCS LEAD (2)
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