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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 07/19/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported during a lead revision procedure on (b)(6) 2019, reference mfr. Report #:3 006705815-2019-02251 and 3006705815-2019-02252. The patient's original ipg was removed. The ipg was also placed into surgery mode. However, upon replacing the ipg, the clinician's programmer reflected the error message "unable to be repaired". After troubleshooting, the message went away and the ipg was recovered. The same ipg was re-implanted. The patient has effective therapy following the procedure.
 
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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 Key8871185
MDR Text Key153588375
Report Number1627487-2019-08648
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
Report Date 09/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/17/2021
Device Model Number3660
Device Lot Number6814293
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 Received08/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2019
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: 08/07/2019 Patient Sequence Number: 1
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