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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG Back to Search Results
Model Number 3660
Device Problems Disconnection (1171); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/11/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 1627487-2020-22356.It was reported during post-op programming, diagnostic testing revealed high lead impedance values.X-rays were taken and confirmed that the lead had pulled out of the ipg header.In turn, surgical intervention was undertaken on (b)(6) 2020 wherein the lead was reinserted into the ipg.This addressed the issue.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10217933
MDR Text Key197125412
Report Number1627487-2020-22358
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020192
UDI-Public05415067020192
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/10/2021
Device Model Number3660
Device Catalogue Number3660
Device Lot Number6980146
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS LEAD; SCS LEAD
Patient Outcome(s) Other;
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