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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 Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/08/2019
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 results / method and conclusion codes along with investigation results will be provided on the final report.
 
Event Description
It was reported that the patient experienced a loss of therapy following an unrelated procedure. As a result, surgical intervention may be pending to address the issue.
 
Manufacturer Narrative
An inoperable implant was reported to abbott. The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used. The implant was not returned for analysis. 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.
 
Event Description
Information indicates that ipg was not placed in surgery mode during the unrelated surgery. The ipg did not communicate with external devices following the unrelated surgery and troubleshooting was unable to resolve the issue. New information received, indicated that surgical intervention took place on (b)(6) 2020 wherein the entire system was explanted.
 
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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 Key8940177
MDR Text Key155845152
Report Number1627487-2019-09822
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/08/2020
Device Model Number3660
Device Catalogue Number3660
Device Lot Number6525755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2018
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

Patient Treatment Data
Date Received: 08/28/2019 Patient Sequence Number: 1
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