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); Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2023 |
Event Type
Injury
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Event Description
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It was reported that following a deep brain stimulation (dbs) lead fixation revision procedure the patient began experiencing charging difficulties and loss of stimulation.The patient was educated on charging techniques, but the issue persisted.The patient underwent an implantable pulse generator (ipg) revision procedure where the device was explanted and replaced, and the patient is doing well post-operatively.
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Manufacturer Narrative
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The reported event of the ipg being unable to charge following a lead revision procedure was confirmed.The returned ipg was unable to be charged following three, four-hour charge cycles.The ipg was cut opened and connected to a power supply and the device exhibited high sleep current of 29.3ma.Electrical testing revealed a low vh resistance measurement of 391 ohms, which indicates an electrical short within the application-specific integrated circuit (asic).The damaged asic resulted in the premature battery depletion post lead fixation revision.This type of damage is typically caused when the ipg is exposed to high voltage transients, high current sources, and high radio frequency (rf) energy.Exposure to electrocautery can cause this type of damage.The ipg was likely damaged during the procedure due to unintended use error.
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Event Description
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It was reported that following a deep brain stimulation (dbs) lead fixation revision procedure the patient began experiencing charging difficulties and loss of stimulation.The patient was educated on charging techniques, but the issue persisted.The patient underwent an implantable pulse generator (ipg) revision procedure where the device was explanted and replaced, and the patient is doing well post-operatively.
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Search Alerts/Recalls
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