Model Number 3711 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Information (3190)
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Event Date 02/09/2015 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05107.It was reported the patient (b)(6) experienced heating while recharging their ipg.A replacement charging system will be sent to the patient to address the 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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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05107.
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Manufacturer Narrative
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This charger model was associated with a field correction.Manufacturer's evaluation: corrective and preventive action capa) investigation was performed.Result - pocket heating confirmed.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.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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(b)(4).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 3 reference mfr.Report#: 1627487-2015-05107 reference mfr.Report#: 1627487-2015-05184 follow-up revealed the replacement charging system did not provide resolution to the patient's pocket heating issue.In turn, another replacement charging system will be sent to the patient.
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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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Search Alerts/Recalls
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