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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 Problems Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/21/2019
Event Type  malfunction  
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 results / method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that patient¿s ipg failed to established communication with external devices after a hip replacement surgical procedure. Reportedly, the ipg was set into surgery mode during the procedure. Field representative was able to recover connection after troubleshooting. Issue has been resolved.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system. Based on the information received, the cause of the reported incident is consistent with user error.
 
Manufacturer Narrative
Date was inadvertently left out of report manufacturer report number 1627487-2019-10224.
 
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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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8984093
MDR Text Key157311788
Report Number1627487-2019-10224
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/11/2018
Device Model Number3662
Device Lot Number5758832
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 Received11/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C

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