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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3660
Device Problems Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

It was reported the patient placed their device into mri mode approximately one year ago and the device was never taken out of mri mode. Abbott representative tried to connect to the ipg to no avail. Patient does not know her credentials. Surgical intervention may take place at a later date.

 
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Brand NamePROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
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
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10525183
MDR Text Key206712777
Report Number1627487-2020-31364
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/21/2019
Device MODEL Number3660
Device Catalogue Number3660
Device LOT Number6011904
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/21/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 09/11/2020 Patient Sequence Number: 1
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