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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 12/21/2015
Event Type  Injury  
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. (b)(4).
 
Event Description
It was reported the patient's ipg randomly powers off without prompting. Subsequently, surgical intervention was undertaken during which time the ipg was explanted and replaced. Stimulation was restored postoperatively. The issue is 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.
 
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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
melissa nkematu
6901 preston rd
plano, TX 75024
9723092520
MDR Report Key5780073
MDR Text Key49123116
Report Number3006705815-2016-00274
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 08/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Model Number3771
Device Lot Number5225592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2015
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: 07/08/2016 Patient Sequence Number: 1
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