Model Number 3788 |
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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This ipg serial number was included in a field correction.(b)(4).
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-23498.It was reported the patient experienced uncomfortable heating at the ipg site while recharging.The patient was sent a replacement le charging system to address the issue.Follow-up information revealed the patient received the new charging system which resolved the reported issue.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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Manufacturer Narrative
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Return date was reported in error on the previous report (reference report#: 1627487-2015-23407-001).The device return was reported under mfr report# 1627487-2015-23526-001.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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Search Alerts/Recalls
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