BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number DB-1140 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/25/2020 |
Event Type
malfunction
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Event Description
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It was reported that post lead revision procedures to address high impedances, the patient received an elective replacement indicator eri message on the remote control for the implantable pulse generator ipg.Database analysis was performed using the patients energy using index eui and premature battery depletion was suspected.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding if any surgical intervention has occurred.
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Manufacturer Narrative
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Device technical analysis: the ipg involved in this complaint was discarded at the facility and will not be returned for analysis, therefore, a technical analysis could not be performed.However, analysis of the data downloaded from the ipg was conducted.The database analysis determined that the lower battery voltages were noted in september probably due to a higher battery load due to the high impedances on both right and left leads.Once the leads were replaced and the impedance issues were resolved, the battery load decreased.Investigation conclusion: based on all available information, engineers determined through ipg database analysis that lower battery voltages were noted in september probably due to a higher battery load due to the high impedances on the leads.Once leads replaced and impedance issues resolved the battery load decreased.This is a normal characteristic of an ipg.Therefore, no problem was detected with the ipg.
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Event Description
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It was reported that post lead revision procedures to address high impedances, the patient received an elective replacement indicator eri message on the remote control for the implantable pulse generator ipg.Database analysis was performed using the patients energy usage index eui and premature battery depletion was suspected.
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