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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE SCS IPG Back to Search Results
Model Number 3662
Device Problem Device Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Date 05/30/2018
Event Type  Injury  
Manufacturer Narrative

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. 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 the patient was unable to communicate with the ipg following an unrelated hip replacement procedure. At this time, the next course of action is yet to be determined.

 
Event Description

Follow-up identified additional troubleshooting was attempted by the field representative; however, communication could not be established with the ipg.

 
Event Description

Follow-up identified the patient's ipg was not placed in surgery mode prior to hip surgery. Surgical intervention was undertaken on (b)(6) 2018 to explant and replace the ipg. Stimulation was re-established following the procedure.

 
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Brand NamePROCLAIM 7 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
Manufacturer Contact
palka sharma
9725264823
MDR Report Key7596930
MDR Text Key110941130
Report Number1627487-2018-05672
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,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 08/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/09/2019
Device MODEL Number3662
Device LOT Number6082628
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 Received08/01/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/09/2017
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

Patient TREATMENT DATA
Date Received: 06/13/2018 Patient Sequence Number: 1
Treatment
MODEL 3228, SCS LEAD
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