Model Number 3721 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 08/23/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.This charger model was associated with 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.(b)(4).
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Event Description
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Device 1 of 2.Reference mfr report #1627487-2016-04785.It was reported the patient experienced pocket heating at the ipg site while recharging.Reportedly, surgical intervention may be undertaken as the next course of action.On 08/01/2012 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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Manufacturer Narrative
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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#1627487-2016-04785.Follow-up identified surgical intervention was undertaken during which time the ipg was explanted and replaced with a new model.The patient was implanted with a non-rechargeable ipg.The issue is resolved.
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Search Alerts/Recalls
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