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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 08/22/2019
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.
 
Event Description
It was reported the patient underwent an unrelated surgical procedure. Since the procedure, the patient's ipg has been unable to communicate with their external device due to it being inoperable. Troubleshooting attempts have been unable to provide resolution. As a result, the patient had the ipg replaced. Therapy has successfully been restored post-op.
 
Manufacturer Narrative
Corrected data: method code should not include - testing of actual/suspected device and results code - inadequate immunity.
 
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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 Key8962851
MDR Text Key156558822
Report Number1627487-2019-09988
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
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/25/2019
Device Model Number3660
Device Lot Number6070166
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 Received09/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2017
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: 09/04/2019 Patient Sequence Number: 1
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