Model Number 3721 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete event, patient and device information.Event date is unknown.
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Event Description
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It was reported that the patient was experiencing heating at the ipg site.This may be related to recharging.
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Manufacturer Narrative
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The reported event for the generator and charger become hot during charging was confirmed in the investigation for capa 118058.The corrective action for this issue is for the patient to swap out the high energy (he) charger (3721) for a low energy (le) charger (3722).Actions have been taken to prevent reoccurrence.The patient did not participate in the charger swap.
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Search Alerts/Recalls
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