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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION MODEL 3660 PROCLAIM¿ 5 ELITE IPG SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION MODEL 3660 PROCLAIM¿ 5 ELITE IPG SCS IPG Back to Search Results
Model Number 3660
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Sepsis (2067); Infection, Pyrogenic (2246)
Event Date 04/28/2017
Event Type  Injury  
Manufacturer Narrative
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing. 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.
 
Event Description
Device 1 of 2. Reference mfr. Report#: 1627487-2017-02896. It was reported the patient experienced a fever of 102 degrees, chills, and oozing from the incision site on (b)(6) 2017. As a result, the patient was admitted to the hospital for sepsis. In turn, on (b)(6) 2016 the patient underwent surgical intervention wherein the entire scs system was removed due to infection. Additional information revealed the issue resolved following the procedure.
 
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Brand NameMODEL 3660 PROCLAIM¿ 5 ELITE IPG
Type of DeviceSCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key6598983
MDR Text Key76218385
Report Number1627487-2017-02895
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/09/2019
Device Model Number3660
Device Lot Number5887509
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 Received05/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2017
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: 05/30/2017 Patient Sequence Number: 1
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