Model Number 3721 |
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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(b)(4).This charger model was associated with a field correction.Manufacturer's evaluation: corrective and preventive action (capa) investigation was performed.Evaluation codes: results: pocket heating was 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.Udi (di): (b)(4).
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Event Description
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Device 2 of 2.Reference mfr.Report #1627487-2016-01862.The patient reported he experienced scs ipg pocket heating while charging.The next course of action is undetermined at this time.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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Event Description
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Device 2 of 2:
reference mfr report: 1627487-2016-01862.Follow up information identified the patient underwent surgical intervention where the ipg was replaced with a new one.(reference mfr 1627487-2016-03252 for depleted ipg).
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Search Alerts/Recalls
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