Model Number 3788 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 01/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Field advisory: 1627487-07262012-001-c.This ipg serial number was included in a field advisory and a field correction.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2016-00725.It was reported the patient ((b)(6)) experienced pocket heating at the ipg site while charging the ipg for about 45 minutes.A sjm representative met with the patient and determined it was the user issue.The issue was resolved and the patient decided to keep the original charger.Date of implant is unknown.On (b)(6) 2012 st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.An increase in prior non-reported heating while charging events and other non-reported events was expected.
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Event Description
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Device 1 of 2 : reference mfr.Report# 1627487-2016-00725.Further follow up identified the implant date for the device, is updated with an availbale information.
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Search Alerts/Recalls
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