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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION CHARGING SYSTEM RECHARGEABLE IPG SCS CHARGING SYSTEM

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ST. JUDE MEDICAL - NEUROMODULATION CHARGING SYSTEM RECHARGEABLE IPG SCS CHARGING SYSTEM Back to Search Results
Model Number 3701
Device Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 10/31/2019
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Reference manufacturer number: 1627487-2019-12871. The investigation for capa (b)(4) associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns. The heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating.
 
Manufacturer Narrative
The ipg was replaced and therapy was restored. 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 event could not be conclusively determined.
 
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Brand NameCHARGING SYSTEM RECHARGEABLE IPG
Type of DeviceSCS CHARGING SYSTEM
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 Key9347947
MDR Text Key167170463
Report Number1627487-2019-12870
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 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/27/2012
Device Model Number3701
Device Catalogue Number3701
Device Lot Number85918
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 Received01/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/07/26/2012/001-C

Patient Treatment Data
Date Received: 11/20/2019 Patient Sequence Number: 1
Treatment
MODEL 3716, SCS IPG
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