Model Number 3711 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Type
Injury
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Manufacturer Narrative
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This charger model was included in a field correction.Manufacturer's evaluation: corrective and preventive action (capa) investigation was performed.Pocket heating was confirmed.The investigation for the capa 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.The manufacturer 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.The manufacturer 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#: 1627487-2018-07660.It was reported the patient experienced heating at the ipg site while recharging.A company representative was scheduled to meet with the patient as the next course of action and evaluate the issue.
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Event Description
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Device 2 of 2: reference mfr.Report#: 1627487-2018-07660.Additional information received indicated no intervention is planned for this issue as it has improved.
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Search Alerts/Recalls
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