Model Number 3721 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 08/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 included in a field correction.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 1 of 2.Reference mfr.Report#: 1627487-2018- 08505.It was reported (b)(6) the patient was experiencing uncomfortable pocket heating while charging.No additional information available at this time.Device information is unavailable at this time.
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Event Description
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Device 1 of 2; reference mfr.Report#: 1627487-2018- 08505.Additional information received identified the charger was replaced with a low energy charger which resolved the issue.
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Search Alerts/Recalls
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