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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 05/15/2018
Event Type  Injury  
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.
 
Event Description
It was reported the patient was unable to communicate with the ipg following an unrelated surgery. As such, the ipg was inoperable. Surgical intervention is planned to address the issue.
 
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.
 
Event Description
Follow-up identified the patient underwent surgical intervention on (b)(6) 2018 to explant and replace the ipg. Stimulation was restored 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 Key7633872
MDR Text Key112171951
Report Number1627487-2018-05932
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/13/2020
Device Model Number3662
Device Lot Number6307452
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 Received08/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2018
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: 06/25/2018 Patient Sequence Number: 1
Treatment
MODEL 3186(2), SCS LEAD
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