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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM¿ 5 ELITE IPG SCS IPG Back to Search Results
Model Number 3660
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  Malfunction  
Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017. 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

(b)(6). It was reported the replace generator soon message was displayed on the patient controller indicating the generator was approaching its end of service. Diagnostics indicated the message was prematurely displayed.

 
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Brand NamePROCLAIM¿ 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 Key7155995
MDR Text Key96113298
Report Number1627487-2017-08812
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/29/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/10/2018
Device MODEL Number3660
Device LOT Number5491494
OTHER Device ID Number05415067020192
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/10/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-09122017-001-C

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