BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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Model Number DB-1216 |
Device Problems
Unexpected Therapeutic Results (1631); Inappropriate or Unexpected Reset (2959)
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Patient Problem
Shaking/Tremors (2515)
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Event Date 12/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that on several occasions the deep brain stimulation (dbs) patient experienced intermittent stimulation, and a return of their tremors when charging the deep brain stimulation (dbs) system.The database analysis performed identified a bluetooth fault code when charging the implantable pulse generator (ipg).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 on several occasions the deep brain stimulation (dbs) patient experienced intermittent stimulation, and a return of their tremors when charging the deep brain stimulation (dbs) system.The database analysis performed identified a bluetooth fault code when charging the implantable pulse generator (ipg).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 to resolve the bluetooth fault code error when charging the ipg.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 9028506-102-00.The patient is able to successfully charge the ipg without interruption.No further action related to this event is needed.
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Event Description
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It was reported that on several occasions the deep brain stimulation (dbs) patient experienced intermittent stimulation, and a return of their tremors when charging the deep brain stimulation (dbs) system.The database analysis performed identified a bluetooth fault code when charging the implantable pulse generator (ipg).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 to resolve the bluetooth fault code error when charging the ipg.
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