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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 Problems Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 07/29/2019
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 the patient¿s ipg was unable to communicate with external devices following an unrelated surgical procedure. A manufacturer representative confirmed the issue and the ipg was deemed inoperable. Surgical intervention may be taken at a later date to address the issue.
 
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete patient information.
 
Event Description
Additional information received stated that the patient underwent surgical intervention on (b)(6) 2020 wherein the ipg was explanted and replaced. Post-operatively, stimulation therapy was restored.
 
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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
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8928628
MDR Text Key155510411
Report Number1627487-2019-09686
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 02/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/19/2020
Device Model Number3660
Device Catalogue Number3660
Device Lot Number6411906
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 Received01/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C

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