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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 Date 04/30/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the ipg turns off when the patient presses on the ipg site. Surgical intervention is planned to address the issue.
 
Event Description
It was reported the patient underwent surgery on (b)(6) 2016. The ipg was explanted and replaced. The patient's issue was resolved.
 
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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
connie timmons
6901 preston road
plano, TX 75024
9723098054
MDR Report Key5680732
MDR Text Key45958216
Report Number3006705815-2016-00214
Device Sequence Number1
Product Code LGW
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
Type of Report Initial,Followup
Report Date 05/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2017
Device Model Number3771
Device Lot Number5069748
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2015
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: 05/25/2016 Patient Sequence Number: 1
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