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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 Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Malfunction  
Manufacturer Narrative

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. The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

 
Event Description

It was reported the patient's ipg became inoperable after the patient underwent a surgical procedure. Troubleshooting was unable to resolve the issue. The next course of action is unknown at this time.

 
Event Description

Follow up revealed that the patient underwent surgery on (b)(6) 2017 to have their ipg replaced. Reportedly, effective therapy was restored post operatively.

 
Manufacturer Narrative

The capa investigation was initiated on (b)(6) 2016 to address the issue of the proclaim ipg (orion ipg family) entering the service application state. The investigation was completed and being monitored by the manufacturer.

 
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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 Key7155347
MDR Text Key96116736
Report Number1627487-2017-08811
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 CONSUMER
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 04/23/2018
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? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/24/2019
Device MODEL Number3660
Device LOT Number5816031
OTHER Device ID Number05415067020192
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/14/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/24/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-060217-001-C

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