BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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Model Number DB-1216 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Event Description
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It was reported that the database analysis performed identified a bluetooth fault code when charging the deep brain stimulation (dbs) implantable pulse generator (ipg) battery.Noise from the charging field of the charger interferes with the bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.No other anomalies were found with the analysis as the device displayed a normal charge log.The ipg remains implanted in the patient and delivering therapy.
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Event Description
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It was reported that the database analysis performed identified a bluetooth fault code when charging the deep brain stimulation (dbs) implantable pulse generator (ipg) battery.Noise from the charging field of the charger interferes with the bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.No other anomalies were found with the analysis as the device displayed a normal charge log.The ipg remains implanted in the patient and delivering therapy.Additional information received indicates that a boston scientific representative, in consultation with the treating clinician, performed an ipg firmware update that has resolved the bluetooth fault code error when charging the ipg.The applicable firmware is model 9028509-101-00.Reference pma approval p150031.The patient is able to successfully charge the ipg without interruption.No further action related to this event is needed.
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