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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE SCS IPG Back to Search Results
Model Number 3660
Device Problem Device Stops Intermittently (1599)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/31/2017
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: the therapy date for the following device is unknown: model: 3189; scs lead, model: 3386, scs extension. 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

It was reported (b)(6) the patient experienced intermittent stimulation. In addition, the patient stated experiencing increased pain due to the issue. Surgical intervention was undertaken to explant and replace the ipg in related reference mfr. Report: 1627487-2018-03052. Explant date is unknown at this time.

 
Event Description

Follow-up identified the patient's ipg was explanted on (b)(6) 2018.

 
Event Description

Follow-up identified the issue of intermittent stimulation has resolved with the new ipg.

 
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Brand NamePROCLAIM 5 ELITE
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 Key7399098
MDR Text Key104435702
Report Number1627487-2018-03360
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/25/2018
Device MODEL Number3660
Device LOT Number5474541
OTHER Device ID Number05415067020192
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/25/2016
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: 04/05/2018 Patient Sequence Number: 1
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