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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 Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
Event Date 07/24/2017
Event Type  Injury  
Manufacturer Narrative
The results / method and conclusion codes along with investigation results will be provided on the final report. Further information was requested but not received.
 
Event Description
Related manufacturer report: 1627487-2019-10737, related manufacturer report: 1627487-2019-10738. It was reported that a surgical intervention is anticipated in the near future for an unknown reason. No further information is available at this time.
 
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.
 
Event Description
New information received states that device system was explanted. There were no compilations during the procedure. Patient was stable.
 
Event Description
New information received states that patient had ineffective stimulation since implant procedure. No further information is available at this time.
 
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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 Key9107394
MDR Text Key159718989
Report Number1627487-2019-10736
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
Type of Report Initial,Followup,Followup,Followup
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/26/2019
Device Model Number3662
Device Lot Number6000222
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 Received11/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/23/2019 Patient Sequence Number: 1
Treatment
SCS LEAD; SCS LEAD
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