Model Number 3721 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Burning Sensation (2146); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).This charger model was associated a field correction.The investigation for capa 118058 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.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 2 of 2.Reference mfr.Report:1627487-2016-04012.The patient reported experiencing uncomfortable heating at his scs ipg pocket site while charging.A replacement low energy charging system was sent to the patient.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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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 2 of 2.Reference mfr.Report:1627487-2016-04012.Additional information received identified surgical intervention will be taken at a later date to address the issue.
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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 2 of 2.Reference mfr.Report:1627487-2016-04012.Additional information received identified the ipg was explanted and replaced which resolved the issue.The ipg is also reported under mfr report number- 1627487-2016-04912.
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Search Alerts/Recalls
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